K771913 is an FDA 510(k) clearance for the HEEL/ELBOW PROTECTOR. This device is classified as a Protector, Skin Pressure (Class I - General Controls, product code FMP).
Submitted by Alba-Waldensian, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1977, 35 days after receiving the submission on October 11, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6450.
| 510(k) Number | K771913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1977 |
| Decision Date | November 15, 1977 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMP — Protector, Skin Pressure |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6450 |