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FDA 510(k)

ShockPhysio Mobile (model SW3200 Basic)

K-Number: K240358 · 2024-06-05

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2024-06-05
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ShockPhysio Mobile (model SW3200 Basic) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-05 under 510(k) number K240358. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ShockPhysio Mobile (model SW3200 Basic)?

ShockPhysio Mobile (model SW3200 Basic) is a medical device that received FDA 510(k) clearance on 2024-06-05. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K240358.

When did ShockPhysio Mobile (model SW3200 Basic) receive FDA 510(k) clearance?

ShockPhysio Mobile (model SW3200 Basic) received FDA 510(k) clearance on 2024-06-05, under 510(k) number K240358.

Who is the listed applicant for ShockPhysio Mobile (model SW3200 Basic)?

The FDA 510(k) record lists Shenzhen Dongdixin Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ShockPhysio Mobile (model SW3200 Basic)?

The FDA product code for ShockPhysio Mobile (model SW3200 Basic) is ISA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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