The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Well Life Wireless Tens/ems Stimulator, Models Wr-2605/2605a.
| Device ID | K161453 |
| 510k Number | K161453 |
| Device Name: | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 1F, NO.16, LANE 454 JUNGJENG ROAD Yunghe City, Taipei County, TW 234 |
| Contact | Chin-chih Hsieh |
| Correspondent | Chin-chih Hsieh WELL-LIFE HEALTHCARE LIMITED 1F, NO.16, LANE 454 JUNGJENG ROAD Yunghe City, Taipei County, TW 234 |
| Product Code | NUH |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-26 |
| Decision Date | 2016-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20856675008056 | K161453 | 000 |
| 00856675008007 | K161453 | 000 |
| 10853635002447 | K161453 | 000 |
| 00853635002433 | K161453 | 000 |
| 04719872266051 | K161453 | 000 |
| 00856675008755 | K161453 | 000 |
| 00856675008724 | K161453 | 000 |