The following data is part of a premarket notification filed by Stimq Llc with the FDA for Stimq Peripheral Nerve Stimulator (pns) System.
| Device ID | K152178 |
| 510k Number | K152178 |
| Device Name: | StimQ Peripheral Nerve Stimulator (PNS) System |
| Classification | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Applicant | STIMQ LLC 901 EAST LAS OLAS BOULEVARD, SUITE 201 Fort Laurderdale, FL 33301 |
| Contact | Elizabeth Greene |
| Correspondent | Elizabeth Greene STIMQ LLC 901 EAST LAS OLAS BOULEVARD, SUITE 201 Fort Laurderdale, FL 33301 |
| Product Code | GZF |
| CFR Regulation Number | 882.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-04 |
| Decision Date | 2016-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850051034437 | K152178 | 000 |
| 00850051034307 | K152178 | 000 |
| 00850051034291 | K152178 | 000 |
| 00850051034284 | K152178 | 000 |
| 00850051034208 | K152178 | 000 |
| 00850051034192 | K152178 | 000 |
| 00850051034185 | K152178 | 000 |
| 00850051034277 | K152178 | 000 |
| 00850051034253 | K152178 | 000 |
| 00850051034178 | K152178 | 000 |
| 00850051034314 | K152178 | 000 |
| 00850051034321 | K152178 | 000 |
| 00850051034338 | K152178 | 000 |
| 00850051034420 | K152178 | 000 |
| 00850051034413 | K152178 | 000 |
| 00850051034406 | K152178 | 000 |
| 00850051034390 | K152178 | 000 |
| 00850051034383 | K152178 | 000 |
| 00850051034376 | K152178 | 000 |
| 00850051034369 | K152178 | 000 |
| 00850051034352 | K152178 | 000 |
| 00850051034345 | K152178 | 000 |
| 00850051034161 | K152178 | 000 |