The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Well Life Rx Wireless Tens/ems Stimulator, Model Wr-2603/2603a, Wr-2604/2604a And Wr-2605/2605a.
| Device ID | K162663 |
| 510k Number | K162663 |
| Device Name: | WELL LIFE Rx Wireless TENS/EMS Stimulator, Model WR-2603/2603A, WR-2604/2604A And WR-2605/2605A |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 1F, NO. 16, LANE 454, JUNGJENG ROAD Yunghe District, New Taipei City, TW 234 |
| Contact | Chin-chih Hsieh |
| Correspondent | Chin-chih Hsieh WELL-LIFE HEALTHCARE LIMITED 1F, NO. 16, LANE 454, JUNGJENG ROAD Yunghe District, New Taipei City, TW 234 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2017-01-17 |