Refusal Actions by FDA as Recorded in OASIS
Manufacturer FEI: 3007001300
Manufacturer Name: Flying International (Macao) Ltd
Manufacturer address line 1: Edif Comercial I Tak 19 Andar Brua
Manufacturer address line 2:
Manufacturer City: Macaumacau
Manufacturer Province/state:
Manufacturer Country: Macau
Product code: 89I--LJ
Importers product description: ERR-CBP/FOOT SPA SAMPLES
Refusal date: 03-OCT-2008
FDA_District: CIN-DO
Entry/doc/line/sfx: UPS-2380999-7/1/1/
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
FAILS STD
NO 510(K)
Manufacturer FEI: 3006847147
Manufacturer Name: Silkroad International
Manufacturer address line 1: 12 Asia Industrial Park
Manufacturer address line 2:
Manufacturer City: Shenzen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 89I--LJ
Importers product description: FOOTBATH
Refusal date: 14-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: AEK-9690916-9/1/1/
Carrier: EVA AIRWAYS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
NO 510(K)
Manufacturer FEI: 3007065509
Manufacturer Name: Hong Kong Intl Co Ltd
Manufacturer address line 1: 158 Huancheng W Rd
Manufacturer address line 2:
Manufacturer City: Ningbo
Manufacturer Province/state:
Manufacturer Country: China
Product code: 89I--MA
Importers product description: ICE GEL
Refusal date: 20-OCT-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: ADM-0025886-0/8/1/
Carrier: MSC-MEDITERRANEAN SHIPPING CO
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3001585912
Manufacturer Name: Web-Tex, Inc.
Manufacturer address line 1: 5445 De Gaspe
Manufacturer address line 2: suite 702
Manufacturer City: Montreal
Manufacturer Province/state: QC
Manufacturer Country: Canada
Product code: 89I--ME
Importers product description: COLD PACK
Refusal date: 24-OCT-2008
FDA_District: DET-DO
Entry/doc/line/sfx: 551-7562875-4/11/1/
Carrier: NINE ZERO NINE FOUR-SIX NINE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3006993664
Manufacturer Name: Pyunghwa Industrial Co. - Hula Hoop Mfg.
Manufacturer address line 1: Unknown St
Manufacturer address line 2:
Manufacturer City: Unknown
Manufacturer Province/state:
Manufacturer Country: Korea, Republic Of (South)
Product code: 89I--SA
Importers product description: Magnetic (II) Health Hoop - Ilban (II)
Refusal date: 17-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: CAY-1006889-5/75/1/B
Carrier: NYK LINE (NIPPON YUSEN KAISHA
Bill of Lading: NYKS47550501
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3006993664
Manufacturer Name: Pyunghwa Industrial Co. - Hula Hoop Mfg.
Manufacturer address line 1: Unknown St
Manufacturer address line 2:
Manufacturer City: Unknown
Manufacturer Province/state:
Manufacturer Country: Korea, Republic Of (South)
Product code: 89I--SA
Importers product description: Jemimah Health Hoop (II) - Yuemima
Refusal date: 17-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: CAY-1006889-5/75/1/C
Carrier: NYK LINE (NIPPON YUSEN KAISHA
Bill of Lading: NYKS47550501
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3007140574
Manufacturer Name: Teadmedics Enterprises Co. Ltd
Manufacturer address line 1: 529258 Chao Jing
Manufacturer address line 2:
Manufacturer City: Tai Shan City
Manufacturer Province/state:
Manufacturer Country: China
Product code: 89I--SA
Importers product description: ELECTRIC FOOT MASSAGER
Refusal date: 22-OCT-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: 112-4624556-0/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DEVICEGMPS
Manufacturer FEI: 3006762620
Manufacturer Name: Sing Kwong Trading Company
Manufacturer address line 1: 26ng Fong St
Manufacturer address line 2:
Manufacturer City: Kowloon
Manufacturer Province/state:
Manufacturer Country: Hong Kong SAR
Product code: 89I--SA
Importers product description: SKIN SCRUBBER(FORMAL ENTRY PER FDA REQUESTED)
Refusal date: 31-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: AEK-9696613-6/1/1/
Carrier: POLAR AIR CARGO, INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
NO 510(K)
Manufacturer FEI: 3006762620
Manufacturer Name: Sing Kwong Trading Company
Manufacturer address line 1: 26ng Fong St
Manufacturer address line 2:
Manufacturer City: Kowloon
Manufacturer Province/state:
Manufacturer Country: Hong Kong SAR
Product code: 89I--SA
Importers product description: MICRODERMABRASION MACHINE(FORMAL ENTRY PER FDA REQUESTED)
Refusal date: 31-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: AEK-9696613-6/1/2/
Carrier: POLAR AIR CARGO, INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
NO 510(K)
Manufacturer FEI: 3006762620
Manufacturer Name: Sing Kwong Trading Company
Manufacturer address line 1: 26ng Fong St
Manufacturer address line 2:
Manufacturer City: Kowloon
Manufacturer Province/state:
Manufacturer Country: Hong Kong SAR
Product code: 89I--SA
Importers product description: BREAST MASSAGE DEVICE(FORMAL ENTRY PER FDA REQUESTED)
Refusal date: 31-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: AEK-9696613-6/1/3/
Carrier: POLAR AIR CARGO, INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NO 510(K)
Manufacturer FEI: 3006762620
Manufacturer Name: Sing Kwong Trading Company
Manufacturer address line 1: 26ng Fong St
Manufacturer address line 2:
Manufacturer City: Kowloon
Manufacturer Province/state:
Manufacturer Country: Hong Kong SAR
Product code: 89I--SA
Importers product description: PHOTON LED DEVICE(FORMAL ENTRY PER FDA REQUESTED)
Refusal date: 31-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: AEK-9696613-6/1/4/
Carrier: POLAR AIR CARGO, INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3006762620
Manufacturer Name: Sing Kwong Trading Company
Manufacturer address line 1: 26ng Fong St
Manufacturer address line 2:
Manufacturer City: Kowloon
Manufacturer Province/state:
Manufacturer Country: Hong Kong SAR
Product code: 89I--SA
Importers product description: MICRO CURRENT MACHINE(FORMAL ENTRY PER FDA REQUESTED)
Refusal date: 31-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: AEK-9696613-6/1/5/
Carrier: POLAR AIR CARGO, INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NO 510(K)
Manufacturer FEI: 3007112170
Manufacturer Name: Aquanox
Manufacturer address line 1: Av Americas 39 10
Manufacturer address line 2:
Manufacturer City: Bogotabogota
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 89L--BF
Importers product description: EQUIPO VACUMTERAPIA
Refusal date: 14-OCT-2008
FDA_District: CIN-DO
Entry/doc/line/sfx: UPS-2318906-9/1/1/A
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3007112170
Manufacturer Name: Aquanox
Manufacturer address line 1: Av Americas 39 10
Manufacturer address line 2:
Manufacturer City: Bogotabogota
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 89L--BF
Importers product description: DEVICE THERAPY/THERMO VIBRATOR BLANKET-FOR PERSOANLUSE ONLY
Refusal date: 14-OCT-2008
FDA_District: CIN-DO
Entry/doc/line/sfx: UPS-2318906-9/1/2/
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
FAILS STD
NO 510(K)
NO ENGLISH
Manufacturer FEI: 3007112170
Manufacturer Name: Aquanox
Manufacturer address line 1: Av Americas 39 10
Manufacturer address line 2:
Manufacturer City: Bogotabogota
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 89L--PQ
Importers product description: GIMNASIA PASIVA
Refusal date: 14-OCT-2008
FDA_District: CIN-DO
Entry/doc/line/sfx: UPS-2318906-9/1/1/B
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3004152705
Manufacturer Name: Shenzhen Xunfengtong Electronic Co., LTD
Manufacturer address line 1: 4/F, 7 Building, Changye Road
Manufacturer address line 2: 28 District, Baoan
Manufacturer City: Shenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 89L--YG
Importers product description: MASSAGER, THERAPEUTIC, MANUAL;;
Refusal date: 15-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: M51-0013982-8/1/1/
Carrier: CHINA OCEAN SHIPPING COMPANY
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3004152705
Manufacturer Name: Shenzhen Xunfengtong Electronic Co., LTD
Manufacturer address line 1: 4/F, 7 Building, Changye Road
Manufacturer address line 2: 28 District, Baoan
Manufacturer City: Shenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 89L--YG
Importers product description: MASSAGER, THERAPEUTIC, MANUAL;;
Refusal date: 15-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: M51-0013982-8/2/1/
Carrier: CHINA OCEAN SHIPPING COMPANY
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3006472698
Manufacturer Name: Osiris Inc
Manufacturer address line 1: 2 Finley Rd
Manufacturer address line 2:
Manufacturer City: Brampton
Manufacturer Province/state:
Manufacturer Country: Canada
Product code: 89L--YG
Importers product description: SLENDER SONIC
Refusal date: 22-OCT-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: 144-1964855-8/4/1/
Carrier: YORK TRANSPORTATION INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): RX DEVICE
FALSE
NO 510(K)
Manufacturer FEI: 3004564811
Manufacturer Name: Changshu Dayou Import Export
Manufacturer address line 1: 2f Block B Internation Trade Bldgno 172
Manufacturer address line 2:
Manufacturer City: Jiangsu
Manufacturer Province/state:
Manufacturer Country: China
Product code: 89M--LX
Importers product description: WIPES
Refusal date: 06-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: 442-0167832-1/2/1/
Carrier: HYUNDAI MERCHANT MARINE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3006472698
Manufacturer Name: Osiris Inc
Manufacturer address line 1: 2 Finley Rd
Manufacturer address line 2:
Manufacturer City: Brampton
Manufacturer Province/state:
Manufacturer Country: Canada
Product code: 89M--LX
Importers product description: Kiyoshi Detox Foot Patches
Refusal date: 22-OCT-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: 144-1964855-8/9/1/B
Carrier: YORK TRANSPORTATION INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3005601111
Manufacturer Name: Power Paper
Manufacturer address line 1: 21 Yegia Kapayim, Kiryat Arye
Manufacturer address line 2:
Manufacturer City: Petach Tikva
Manufacturer Province/state:
Manufacturer Country: Israel
Product code: 89M--PH
Importers product description: POWER MASK MASQUE IONIQUE YEUX
Refusal date: 17-OCT-2008
FDA_District: BLT-DO
Entry/doc/line/sfx: 322-3149448-8/33/1/
Carrier: HAPAG LLOYD A G
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3006472698
Manufacturer Name: Osiris Inc
Manufacturer address line 1: 2 Finley Rd
Manufacturer address line 2:
Manufacturer City: Brampton
Manufacturer Province/state:
Manufacturer Country: Canada
Product code: 89M--VT
Importers product description: Foot Insoles
Refusal date: 22-OCT-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: 144-1964855-8/9/1/A
Carrier: YORK TRANSPORTATION INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3006979420
Manufacturer Name: Shanghai Trend International Trade Co Ltd
Manufacturer address line 1: Yanhu Area Wenzhou
Manufacturer address line 2:
Manufacturer City: Zhenjian
Manufacturer Province/state:
Manufacturer Country: China
Product code: 89N--XU
Importers product description: FOOT SPA
Refusal date: 31-OCT-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: AEK-9695678-0/1/1/
Carrier: CHINA AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3007136693
Manufacturer Name: Lipika Tech
Manufacturer address line 1: 75 11th Cross Woc Road 2nd
Manufacturer address line 2:
Manufacturer City: Bangalorebangalore
Manufacturer Province/state:
Manufacturer Country: India
Product code: 89N--YZ
Importers product description: ERR CBP 006 / MAGNETIC SIGNAL GENERATORS
Refusal date: 16-OCT-2008
FDA_District: CIN-DO
Entry/doc/line/sfx: UPS-2443760-8/1/1/
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
FAILS STD
REGISTERED
NO 510(K)