K803064 is an FDA 510(k) clearance for the ZIMMER ELECTRICAL MUSCLE STIMULATOR. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1980, 27 days after receiving the submission on December 4, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K803064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 1980 |
| Decision Date | December 31, 1980 |
| Days to Decision | 27 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 |