The following data is part of a premarket notification filed by Thimble Bioelectronics, Inc. with the FDA for Cur Model 1.
| Device ID | K160052 |
| 510k Number | K160052 |
| Device Name: | CUR Model 1 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Thimble Bioelectronics, Inc. 2011 26th St. Ste. 202 San Francisco, CA 94107 |
| Contact | Shaun Rahimi |
| Correspondent | Shaun Rahimi Thimble Bioelectronics, Inc. 2011 26th St. Ste. 202 San Francisco, CA 94107 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-11 |
| Decision Date | 2016-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195893606580 | K160052 | 000 |
| 00195893670284 | K160052 | 000 |
| 00850045950019 | K160052 | 000 |
| 00850045950002 | K160052 | 000 |
| 00850045950033 | K160052 | 000 |
| 00850045950026 | K160052 | 000 |