ShockPhysio Mobile (model SW3200 Basic)
FDA 510(k) K240358 · Shenzhen Dongdixin Technology Co., Ltd.
510(k) numberK240358
Submission
- Device name
- ShockPhysio Mobile (model SW3200 Basic)
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
Shenzhen, CN - Received
- February 6, 2024
- Decision date
- June 5, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ISA – Massager, Therapeutic, Electric
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5660
- Specialty
- Physical Medicine
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Questions and answers
When was ShockPhysio Mobile (model SW3200 Basic) cleared by the FDA?
ShockPhysio Mobile (model SW3200 Basic) (K240358) received a 510(k) decision of Substantially Equivalent on June 5, 2024, 120 days after the submission was received.
What is the product code of K240358?
The FDA product code is ISA – Massager, Therapeutic, Electric, a Class I (low risk) device regulated under 21 CFR 890.5660.