Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K203513 |
Device Name |
SLENDERTONE Evolve Abs, Type 735 |
Applicant |
Bio-Medical Research Ltd |
Parkmore Business Park West |
Galway,
IE
H91 NHT7
|
|
Applicant Contact |
Eoin Keating |
Correspondent |
Bio-Medical Research Ltd |
Parkmore Business Park West |
Galway,
IE
H91 NHT7
|
|
Correspondent Contact |
Eoin Keating |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 11/30/2020 |
Decision Date | 02/10/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|