Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K152954 |
Device Name |
Quell |
Applicant |
NEUROMETRIX, INC. |
1000 WINTER STREET |
WALTHAM,
MA
02451
|
|
Applicant Contact |
RAINER MAAS |
Correspondent |
NEUROMETRIX, INC. |
1000 WINTER STREET |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
RAINER MAAS |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 10/07/2015 |
Decision Date | 01/05/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|