K831910 is an FDA 510(k) clearance for the STRYKER LEG EXERCISER. This device is classified as a Exerciser, Powered (Class I - General Controls, product code BXB).
Submitted by Stryker Corp. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983, 28 days after receiving the submission on June 14, 1983.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5380.
| 510(k) Number | K831910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1983 |
| Decision Date | July 12, 1983 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | BXB — Exerciser, Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5380 |