Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K211942 |
Device Name |
Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) |
Applicant |
Shenzhen OSTO Technology Company Limited |
No.43 Longfeng Road, Xinsheng Community, Longgang Street, |
Longgang District |
Shenzhen,
CN
518116
|
|
Applicant Contact |
Li Yang |
Correspondent |
Guangzhou GLOMED Biological Technology Co., Ltd. |
2231, Building 1, Rui Feng Center, Kaichuang Road, |
Huangpu District |
Guangzhou,
CN
510663
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/23/2021 |
Decision Date | 12/13/2021 |
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
|
|
|