The following data is part of a premarket notification filed by Easymed Instrument Co., Ltd. with the FDA for Easystim Nms-28.
| Device ID | K050921 |
| 510k Number | K050921 |
| Device Name: | EASYSTIM NMS-28 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | EASYMED INSTRUMENT CO., LTD. 2/F-3/F, NO.2 BEIHAI DA ROAD LUNJIAO, SHUNDE Guangdong, CN 528303 |
| Contact | Jeffery Wu |
| Correspondent | Jeffery Wu EASYMED INSTRUMENT CO., LTD. 2/F-3/F, NO.2 BEIHAI DA ROAD LUNJIAO, SHUNDE Guangdong, CN 528303 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-13 |
| Decision Date | 2005-12-12 |
| Summary: | summary |