K063034 is an FDA 510(k) clearance for the AIR-FLEX WITH AUTO-DISTRACTION. This device is classified as a Table, Physical Therapy, Multi Function (Class II - Special Controls, product code JFB).
Submitted by Hill Laboratories Co. (Frazer, US). The FDA issued a Cleared decision on December 14, 2006, 72 days after receiving the submission on October 3, 2006.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5880.
| 510(k) Number | K063034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2006 |
| Decision Date | December 14, 2006 |
| Days to Decision | 72 days |
| Submission Type | Abbreviated |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | JFB — Table, Physical Therapy, Multi Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5880 |