The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Well-life Otc Ems System.
| Device ID | K102786 |
| 510k Number | K102786 |
| Device Name: | WELL-LIFE OTC EMS SYSTEM |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW 234 |
| Contact | Jenny Hsieh |
| Correspondent | Jenny Hsieh WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW 234 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-27 |
| Decision Date | 2011-07-01 |
| Summary: | summary |