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 | K141299 |
| 510k Number | K141299 |
| Device Name: | OTC COMBO TENS/EMS SYSTEM |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW 234 |
| Contact | Chin-chih Hsieh |
| Correspondent | Chin-chih Hsieh WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. 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 | 2014-05-19 |
| Decision Date | 2014-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816864020142 | K141299 | 000 |
| 00857771003965 | K141299 | 000 |
| 00853635002259 | K141299 | 000 |
| 04719872264057 | K141299 | 000 |
| B311PEPULSEDUO0 | K141299 | 000 |