Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K191547 |
Device Name |
ReliefBand |
Applicant |
ReliefBand Technologies LLC |
220 Gibraltar Rd Ste 270 |
Horsham,
PA
19044
|
|
Applicant Contact |
Barbara Whitman |
Correspondent |
ReliefBand Technologies LLC |
220 Gibraltar Rd Ste 270 |
Horsham,
PA
19044
|
|
Correspondent Contact |
Barbara Whitman |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 06/12/2019 |
Decision Date | 08/30/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|