The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Mini Patch.
| Device ID | K121353 |
| 510k Number | K121353 |
| Device Name: | MINI PATCH |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW Ch |
| Contact | Chin-chin Hsieh |
| Correspondent | Chin-chin Hsieh WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW Ch |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-04 |
| Decision Date | 2012-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10856675008011 | K121353 | 000 |