Device Classification Name |
Stimulator, Muscle, Powered
|
510(k) Number |
K844390 |
Device Name |
ESCOTEK-EST 204 MULTI STIM |
Applicant |
NOR-AM PATIENT CARE PRODUCTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Applicant Contact |
PAUL A JONES |
Correspondent |
NOR-AM PATIENT CARE PRODUCTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent Contact |
PAUL A JONES |
Regulation Number | 890.5850 |
Classification Product Code |
|
Date Received | 11/13/1984 |
Decision Date | 05/07/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|