INFLATABLE AIR SPLINTS
FDA 510(k) clearance K853600 · decided 1985-09-19
Clearance details
- K-number
- K853600
- Device name
- INFLATABLE AIR SPLINTS
- Applicant
- Hospitak, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-27
- Decision date
- 1985-09-19
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- FZF
- Device class
- 1
- Regulation number
- 878.3900
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lindenhurst, NY, US
- 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 |
|---|---|---|
| COMPRESAID (K881516) | R. Evans Corp. | 1988-04-29 |
| INFLATABLE FULL LEG SPLINT (K874051) | Vinyl Technology, Inc. | 1987-11-23 |
| INFLATABLE FOOT & ANKLE SPLINT (K874050) | Vinyl Technology, Inc. | 1987-11-23 |
| INFLATABLE HALF LEG SPLINT (K874052) | Vinyl Technology, Inc. | 1987-11-23 |
| INFLATABLE FULL ARM SPLINT (K874053) | Vinyl Technology, Inc. | 1987-11-23 |
| URIAS PRESSURE SPLINTS, & FIRST AID (K831764) | Svenol Andersen | 1983-09-12 |
Recalls involving this device
No recalls on record reference this clearance.