K780053 is an FDA 510(k) clearance for the BRACE, TENNIS ELBOW. This device is classified as a Orthosis, Limb Brace (Class I - General Controls, product code IQI).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on January 17, 1978, 8 days after receiving the submission on January 9, 1978.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K780053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1978 |
| Decision Date | January 17, 1978 |
| Days to Decision | 8 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 |