K963091 is an FDA 510(k) clearance for the VOLLMAN PRONE POSITIONER. This device is classified as a Orthosis, Thoracic (Class I - General Controls, product code IPT).
Submitted by Hill-Rom, Inc. (Charleston, US). The FDA issued a Cleared decision on January 9, 1997, 154 days after receiving the submission on August 8, 1996.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.
| 510(k) Number | K963091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1996 |
| Decision Date | January 09, 1997 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPT — Orthosis, Thoracic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3490 |