K941049 is an FDA 510(k) clearance for the MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Smith & Nephew, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 19, 1994, 73 days after receiving the submission on March 7, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K941049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | March 07, 1994 |
| Decision Date | May 19, 1994 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |