K830122 is an FDA 510(k) clearance for the CONTINUOUS ANATOMICAL PASSIVE EXERCISER. This device is classified as a Exerciser, Powered (Class I - General Controls, product code BXB).
Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 7, 1983, 27 days after receiving the submission on January 11, 1983.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5380.
| 510(k) Number | K830122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1983 |
| Decision Date | February 07, 1983 |
| Days to Decision | 27 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 |