K240358
- 510(k) number
- K240358
- Device name
- ShockPhysio Mobile (model SW3200 Basic)
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd. CN
- Product code
- ISA — Massager, Therapeutic, Electric
- Decision date
- 2024-06-05
- Date received
- 2024-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240358
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.