Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K831147 |
Device Name |
OMNIPROBE ELECTRICAL NERVE STIMULATOR |
Applicant |
OMNI INTL., INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
OMNI INTL., INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 04/08/1983 |
Decision Date | 07/18/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|