HOTPAD
FDA 510(k) clearance K915876 · decided 1993-02-12
Clearance details
- K-number
- K915876
- Device name
- HOTPAD
- Applicant
- Ten Comfort Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-19
- Decision date
- 1993-02-12
- Days to decision
- 421 days
- Clearance type
- Traditional
- Product code
- IME
- Device class
- 1
- Regulation number
- 890.5700
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Taiwan R.O.C., CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COLD PACK (K923627) | Friendmed Products | 1993-04-14 |
| HOT OR COLD PACK (THERMIPAQ) (K921446) | Thermionics Corp. | 1992-07-13 |
| MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (K905207) | Micro Surgical Instruments Corp. | 1991-01-22 |
| SUBOCCIPITAL ICE PILLOW (K882413) | Ferguson Medical | 1988-11-30 |
| RE-HEATER, HOT PACK (K863654) | K & L Ent. | 1986-10-23 |
| NICE PACK (K832193) | Universal Medical Instrument Corp. | 1983-08-31 |
| ENSWELL (K831899) | Dr. Micheal A. Sabia | 1983-07-07 |
| MICROPAK MOIST HEAT PAD (K830981) | Micropak Manufacturers, Inc. | 1983-06-03 |
| ICY COLD ICE CAP (K830416) | Ladora Ent. | 1983-03-10 |
| THERMOELASTOMER HOT/COLD COMPRESS BK7186 (K823649) | Fred Sammons, Inc. | 1983-01-21 |
| THERMOELASTOMER HOT/COLD COMPRESS-7187- (K823650) | Fred Sammons, Inc. | 1983-01-21 |
| HOT/COLD PACK HOLDERS (K823814) | Danek Medical, Inc. | 1983-01-14 |
Recalls involving this device
No recalls on record reference this clearance.