Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K080221 |
Device Name |
EA STIMULATOR |
Applicant |
HELIO MEDICAL SUPPLIES, INC. |
606 CHARCOT AVE. |
SAN JOSE,
CA
95131
|
|
Applicant Contact |
YUKUO HSO |
Correspondent |
HELIO MEDICAL SUPPLIES, INC. |
606 CHARCOT AVE. |
SAN JOSE,
CA
95131
|
|
Correspondent Contact |
YUKUO HSO |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 01/29/2008 |
Decision Date | 09/09/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|