Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K961050 |
Device Name |
RELIEFBAND TENS UNIT (MODIFICATION) |
Applicant |
MAVEN LABS, INC. |
1233 20TH ST. N.W. |
SUITE 700 |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
DANIEL J MANELLI |
Correspondent |
MAVEN LABS, INC. |
1233 20TH ST. N.W. |
SUITE 700 |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
DANIEL J MANELLI |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 02/08/1996 |
Decision Date | 08/01/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|