The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Well-life Mini Tens Stimulator(wl-23xxc/wl-23xxe Series).
| Device ID | K220524 |
| 510k Number | K220524 |
| Device Name: | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Well-Life Healthcare Limited 6F., No.168, Lide St., Jhonghe District New Taipei City, TW 23512 |
| Contact | Jenny Hsieh |
| Correspondent | Jenny Hsieh Well-Life Healthcare Limited 6F., No.168, Lide St., Jhonghe District New Taipei City, TW 23512 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-23 |
| Decision Date | 2022-08-04 |