MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
FDA 510(k) clearance K963480 · decided 1997-01-22
Clearance details
- K-number
- K963480
- Device name
- MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
- Applicant
- Deroyal Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-03
- Decision date
- 1997-01-22
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- KID
- Device class
- 1
- Regulation number
- 890.3910
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Powell, TN, 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 |
|---|---|---|
| WHEELCHAIR BELT (K963479) | Deroyal Industries, Inc. | 1997-01-24 |
| PONCHO VEST RESTRAINT (K963475) | Deroyal Industries, Inc. | 1997-01-22 |
| SUPPORT VEST (K963459) | Skil-Care Corp. | 1996-10-15 |
| SAFETY PONCHO/SHOULDER STRAP PONCHO (K963461) | Skil-Care Corp. | 1996-10-11 |
| SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL (K963455) | Skil-Care Corp. | 1996-10-08 |
| ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION (K802603) | Jefferson Industries, Inc. | 1980-11-12 |
Recalls involving this device
No recalls on record reference this clearance.