Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K150308 |
Device Name |
Palm TENS |
Applicant |
HEAT IN A CLICK LLC |
1924 TIGERTAIL BLVD |
DANIA,
FL
33304
|
|
Applicant Contact |
GUY LEVI |
Correspondent |
REGULATORY INSIGHT, INC. |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Correspondent Contact |
KEVIN WALLS |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 02/09/2015 |
Decision Date | 10/20/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|