Brand Name | THERMOPHORE |
Type of Device | AUTOMATIC MOIST HEAT PACK |
Baseline Brand Name | THERMOPHORE |
Baseline Generic Name | HEAT PACK - AC POWERED |
Baseline Catalogue Number | NA |
Baseline Model Number | 055 |
Baseline Device Family | THERMOPHORE |
Baseline Device 510(K) Number | K851237 |
Baseline Device PMA Number | |
Baseline Shelf Life Information |
No
|
Baseline Preamendment? |
Yes
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | NA |
Date First Marketed | 01/01/1913 |
Manufacturer (Section F) |
BATTLE CREEK EQUIPMENT COMPANY |
307 west jackson st. |
battle creek MI 49017 |
|
Manufacturer (Section D) |
BATTLE CREEK EQUIPMENT COMPANY |
307 west jackson st. |
battle creek MI 49017 |
|
Manufacturer (Section G) |
BATTLE CREEK MANUFACTURERS, INC. |
307 west jackson st. |
|
battle creek MI 49017 2385 |
|
Manufacturer Contact |
steven
martin
|
307 west jackson street |
battle creek
, MI 49017 |
(616)
962
-6181
|
|
Device Event Key | 214431 |
MDR Report Key | 221123 |
Event Key | 207478 |
Report Number | 1811605-1999-00065 |
Device Sequence Number | 1 |
Product Code | IRT |
Report Source |
Manufacturer
|
Source Type |
Consumer,Distributor
|
Reporter Occupation |
UNKNOWN
|
Remedial Action |
Repair
|
Type of Report
| Initial |
Report Date |
04/16/1999 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 04/26/1999 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device MODEL Number | 055 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 04/16/1999 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 05/01/1994 |
Is The Device Single Use? |
No
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Reuse
|