Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K232181 |
Device Name |
Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) |
Applicant |
Hebei JT Medical Co., Ltd. |
C12 Hegu Industrial Park, Chaoyang Road, |
Development Zone ZhuoZhou city |
Baoding,
CN
072750
|
|
Applicant Contact |
Karen Liu |
Correspondent |
Beijing STYH Medical Technology Service Co. Ltd. |
No.18, Jianshe Road, Kaixuan Street, Liangxiang Town, |
Fangshan District, |
Beijing,
CN
102488
|
|
Correspondent Contact |
Gina Lian |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 07/24/2023 |
Decision Date | 04/24/2024 |
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
|
|
|