Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K011543 |
Device Name |
TENS CARE, MODEL XL-Y3 |
Applicant |
TENS CARE LTD. |
76, STOCKPORT ROAD |
TIMPERLRY,
GB
WA15 7SN
|
|
Applicant Contact |
BERNARD JOHN TREMAINE |
Correspondent |
TENS CARE LTD. |
76, STOCKPORT ROAD |
TIMPERLRY,
GB
WA15 7SN
|
|
Correspondent Contact |
BERNARD JOHN TREMAINE |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/18/2001 |
Decision Date | 08/31/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|