VOLLMAN PRONE POSITIONER
FDA 510(k) clearance K963091 · decided 1997-01-09
Clearance details
- K-number
- K963091
- Device name
- VOLLMAN PRONE POSITIONER
- Applicant
- Hill-Rom, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-08
- Decision date
- 1997-01-09
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- IPT
- Device class
- 1
- Regulation number
- 890.3490
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Charleston, SC, 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 |
|---|---|---|
| BACK SKPPORTS (K821645) | Fred Sammons, Inc. | 1982-06-11 |
| CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O (K812401) | Surgical Appliance Industries, Inc. | 1981-09-14 |
| MULTITUBULAR THORACIC AIR SPLINTS (K811750) | Roger Cestac & Assoc. | 1981-07-20 |
| LATERAL TRUNK SUPPORTS (K761128) | Fred Sammons, Inc. | 1976-12-02 |
Recalls involving this device
No recalls on record reference this clearance.