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The ShockPhysio Mobile (model SW3200 Basic) is indicated for:

• Relief of minor muscle aches and pains
• Temporary increase in local blood circulation
• Activation of connective tissue

Not Found

This document is a 510(k) clearance letter from the FDA for a therapeutic massager, the "ShockPhysio Mobile (model SW3200 Basic)".

It does not contain any information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or specific study details like those expected for AI/software-based medical devices.

The letter explicitly states: "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This indicates a substantial equivalence (SE) determination, which often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical trials or performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested table and study information based on the provided text. The document is for a Class I Therapeutic Massager (a device with lower regulatory controls), and the FDA clearance process for such devices often focuses more on substantial equivalence to existing devices and adherence to general controls, rather than complex performance studies.

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