The following data is part of a premarket notification filed by Triowave Technologies with the FDA for Painkare.
| Device ID | K151034 |
| 510k Number | K151034 |
| Device Name: | PainKARE |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | TrioWave Technologies 3984 Washington Blvd #166 Fremont, CA 94538 |
| Contact | Huiyou Zhu |
| Correspondent | Parul Chansoria ELEXES Inc. 3984 Washington Blvd #166 Fremont, CA 94538 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-17 |
| Decision Date | 2015-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866946000302 | K151034 | 000 |