Device Classification Name |
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
|
510(k) Number |
K171366 |
Device Name |
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit |
Applicant |
Stimwave Technologies Inc.,DBA StimQ LLC |
901 East Las Olas Boulevard , Suite 201 |
Fort Lauderdale,
FL
33301
|
|
Applicant Contact |
Elizabeth Greene |
Correspondent |
Stimwave Technologies Inc., DBA StimQ LLC |
901 East Las Olas Boulevard , Suite 201 |
Fort Lauderdale,
FL
33301
|
|
Correspondent Contact |
Elizabeth Greene |
Regulation Number | 882.5870
|
Classification Product Code |
|
Date Received | 05/09/2017 |
Decision Date | 08/04/2017 |
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
|
|
|