Device Classification Name |
stimulator, ultrasound and muscle, for use in applying therapeutic deep heat
|
510(k) Number |
K153559 |
Device Name |
OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System |
Applicant |
Accelerated Care Plus (ACP) |
4999 Aircenter Circle, Ste. 103 |
Reno,
NV
89502
|
|
Applicant Contact |
Patrick Parker |
Correspondent |
Accelerated Care Plus (ACP) |
4999 Aircenter Circle, Ste. 103 |
Reno,
NV
89502
|
|
Correspondent Contact |
Patrick Parker |
Regulation Number | 890.5860
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/14/2015 |
Decision Date | 08/26/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|