The following data is part of a premarket notification filed by Pinook Usa with the FDA for Pinook Stimulator.
| Device ID | K132563 |
| 510k Number | K132563 |
| Device Name: | PINOOK STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | PINOOK USA 5703 OBERLIN DRIVE STE 306 San Diego, CA 92121 |
| Contact | Tejas Shah |
| Correspondent | Tejas Shah PINOOK USA 5703 OBERLIN DRIVE STE 306 San Diego, CA 92121 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-15 |
| Decision Date | 2014-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08908008085291 | K132563 | 000 |
| 08908008085277 | K132563 | 000 |