510(k) K240358

ShockPhysio Mobile (model SW3200 Basic) by Shenzhen Dongdixin Technology Co., Ltd. — Product Code ISA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2024
Date Received
February 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Therapeutic, Electric
Device Class
Class I
Regulation Number
890.5660
Review Panel
PM
Submission Type