K780979 is an FDA 510(k) clearance for the AIRSTIRRUP PNEUMATIC ANKLE BRACE. This device is classified as a Orthosis, Limb Brace (Class I - General Controls, product code IQI).
Submitted by Aircast, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1978, 21 days after receiving the submission on June 9, 1978.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K780979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1978 |
| Decision Date | June 30, 1978 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IQI — Orthosis, Limb Brace |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3475 |