Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K233070 |
Device Name |
Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) |
Applicant |
Chongqing Rob Linka Science And Technology Co., Ltd. |
B3-2, Liangjiang Health Science And Technology City, |
No. 2 Yuekang Road, Fuxing Street, Beibei D |
Chongqing,
CN
400700
|
|
Applicant Contact |
Huirong Lu |
Correspondent |
Shanghai CV Technology Co., Ltd. |
Room 602, No. 19 Dongbao Road, Songjiang Area |
Shanghai,
CN
201613
|
|
Correspondent Contact |
Doris Dong |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 09/26/2023 |
Decision Date | 03/13/2024 |
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
|
|
|