The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Otc Patch.
Device ID | K133723 |
510k Number | K133723 |
Device Name: | OTC 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 234 |
Contact | Chin-chin Hsieh |
Correspondent | Chin-chin Hsieh WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW 234 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-06 |
Decision Date | 2014-01-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20050428514454 | K133723 | 000 |
04719872264064 | K133723 | 000 |