ABDUCTION PILLOW
FDA 510(k) clearance K830243 · decided 1983-03-08
Clearance details
- K-number
- K830243
- Device name
- ABDUCTION PILLOW
- Applicant
- Warm & Form, Orthopedic Materials
- Decision
- Substantially Equivalent
- Date received
- 1983-01-25
- Decision date
- 1983-03-08
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- IOZ
- Device class
- 1
- Regulation number
- 890.3665
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ABDUCTION PILLOW (K823820) | Danek Medical, Inc. | 1983-01-14 |
| HIP ABDUCTION SPLINT (K810557) | Orthomedics | 1981-03-13 |
| PAVLIK HARNESS (K780375) | Biomet, Inc. | 1978-03-15 |
Recalls involving this device
No recalls on record reference this clearance.