The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Otc Combo Tens/ems System.
| Device ID | K172809 |
| 510k Number | K172809 |
| Device Name: | OTC Combo TENS/EMS System |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Well-Life Healthcare Limited 1F, No.16, Lane 454, Jungjeng Road Yunghe Dist, 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 Dist, New Taipei City, TW 234 |
| Product Code | NUH |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2017-10-18 |