Device Classification Name |
stimulator, nerve, transcutaneous, for pain relief
|
510(k) Number |
K863567 |
Device Name |
'TENSAID' |
Applicant |
ELECTRO THERAPEUTIC DEVICES, INC. |
570 HOOD RD., STE. 14 |
MARKHAM, ONTARIO,
CA
L3R 4G7
|
|
Applicant Contact |
CHOONG |
Correspondent |
ELECTRO THERAPEUTIC DEVICES, INC. |
570 HOOD RD., STE. 14 |
MARKHAM, ONTARIO,
CA
L3R 4G7
|
|
Correspondent Contact |
CHOONG |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 09/12/1986 |
Decision Date | 10/24/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|