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
|
|
|