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 |