ShockPhysio Mobile (model SW3200 Basic)
FDA 510(k) clearance K240358 · decided 2024-06-05
Clearance details
- K-number
- K240358
- Device name
- ShockPhysio Mobile (model SW3200 Basic)
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-06
- Decision date
- 2024-06-05
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- ISA
- Device class
- 1
- Regulation number
- 890.5660
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.