The following data is part of a premarket notification filed by Dongguan Yingfeng Metal & Plastic Products Co., Ltd with the FDA for Ems Belt (model Mc0485).
| Device ID | K183103 |
| 510k Number | K183103 |
| Device Name: | EMS Belt (Model MC0485) |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Dongguan Yingfeng Metal & Plastic Products Co., Ltd Bianpu District, Lianhu Road, Qiaotou Town Dongguan, CN 523520 |
| Contact | Zesheng Chen |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road Shenzhen, CN 518000 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-07 |
| Decision Date | 2019-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00697294664485 | K183103 | 000 |
| 06972946645703 | K183103 | 000 |
| 06972946643860 | K183103 | 000 |
| 06972946644850 | K183103 | 000 |
| 06972946642962 | K183103 | 000 |
| 06972946643877 | K183103 | 000 |
| 06972946644133 | K183103 | 000 |
| 06972946644652 | K183103 | 000 |
| 06972946645062 | K183103 | 000 |
| 00697294664386 | K183103 | 000 |
| 00850006892754 | K183103 | 000 |