K050921 is an FDA 510(k) clearance for the EASYSTIM NMS-28. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Easy Med Instrument Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on December 12, 2005, 243 days after receiving the submission on April 13, 2005.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K050921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2005 |
| Decision Date | December 12, 2005 |
| Days to Decision | 243 days |
| Submission Type | Abbreviated |
| 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 |