Device Classification Name |
massager, powered inflatable tube
|
510(k) Number |
K201935 |
Device Name |
Air Pressure Therapy System |
Applicant |
Xiamen Weiyou Intelligent Technology Co.,Ltd |
Unit 101-401, No.6 Xianghong Road, Xiang'an District |
Xiamen,
CN
361021
|
|
Applicant Contact |
Yong Sun |
Correspondent |
Shanghai Spica Management Consulting Co.,Ltd. |
609 Room,No.133 Shengang Avenue, Pudong New District |
Shanghai,
CN
201306
|
|
Correspondent Contact |
Sam Lin |
Regulation Number | 890.5650
|
Classification Product Code |
|
Date Received | 07/13/2020 |
Decision Date | 06/22/2021 |
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
|
|
|