MICRO-TEMP PUMPS & MICRO-TEMP PADS
FDA 510(k) clearance K843146 · decided 1984-08-17
Clearance details
- K-number
- K843146
- Device name
- MICRO-TEMP PUMPS & MICRO-TEMP PADS
- Applicant
- Seabrook Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-10
- Decision date
- 1984-08-17
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- ILO
- Device class
- 2
- Regulation number
- 890.5720
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to recall (Z-1129-2015) | Cincinnati Sub-Zero Products Inc | 2015-02-19 |
| Micro-temp II heat therapy unit, model #747. recall (Z-0671-05) | Cincinnati Sub-Zero Products Inc | 2005-04-06 |