Device Classification Name |
stimulator, nerve, transcutaneous, for pain relief
|
510(k) Number |
K021436 |
Device Name |
TTECH MODEL 200E + TENS DEVICE |
Applicant |
THERATECH, INC. |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
THERATECH, INC. |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 05/06/2002 |
Decision Date | 07/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|