Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K081998 |
Device Name |
H-WAVE SPORT |
Applicant |
ELECTRONIC WAVEFORM LABORATORY, INC. |
16168 BEACH BLVD., SUITE 232 |
HUNTINGTON BEACH,
CA
92647
|
|
Applicant Contact |
RYAN P HEANEY |
Correspondent |
ELECTRONIC WAVEFORM LABORATORY, INC. |
16168 BEACH BLVD., SUITE 232 |
HUNTINGTON BEACH,
CA
92647
|
|
Correspondent Contact |
RYAN P HEANEY |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 07/14/2008 |
Decision Date | 07/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|