K792241 is an FDA 510(k) clearance for the PELIMIT. This device is classified as a Device, Warning, Overload, External Limb, Powered (Class II - Special Controls, product code IRN).
Submitted by Colmed, Ltd. (Mchenry, US). The FDA issued a Cleared decision on November 30, 1979, 23 days after receiving the submission on November 7, 1979.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5575.
| 510(k) Number | K792241 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1979 |
| Decision Date | November 30, 1979 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IRN — Device, Warning, Overload, External Limb, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5575 |