Device Classification Name |
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
|
510(k) Number |
K152178 |
Device Name |
StimQ Peripheral Nerve Stimulator (PNS) System |
Applicant |
STIMQ LLC |
901 EAST LAS OLAS BOULEVARD, SUITE 201 |
FORT LAURDERDALE,
FL
33301
|
|
Applicant Contact |
ELIZABETH GREENE |
Correspondent |
STIMQ LLC |
901 EAST LAS OLAS BOULEVARD, SUITE 201 |
FORT LAURDERDALE,
FL
33301
|
|
Correspondent Contact |
ELIZABETH GREENE |
Regulation Number | 882.5870
|
Classification Product Code |
|
Date Received | 08/04/2015 |
Decision Date | 03/11/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|