K033140 is an FDA 510(k) clearance for the NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Everyway Medical Instruments Co.,Ltd (Alpharetta, US). The FDA issued a Cleared decision on October 29, 2003, 29 days after receiving the submission on September 30, 2003.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K033140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2003 |
| Decision Date | October 29, 2003 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |