Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K210825 |
Device Name |
Revitive Medic Coach (Model Number 5575AQ) |
Applicant |
Actegy, Ltd. |
Reflex, Cain Road |
Bracknell,
GB
RG12 1HL
|
|
Applicant Contact |
Lawrence Brookfield |
Correspondent |
The Allis Law Firm, PLLC |
2532 North Fourth Street, #620 |
Flagstaff,
AZ
86004
|
|
Correspondent Contact |
Carmelina Allis |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/19/2021 |
Decision Date | 12/17/2021 |
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
|
|
|