Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)

The Air Pressure Therapy System (models VU-IPC8M, VU-IPC6M, VU-IPC4X) is a powered inflatable massage device with multi-chamber pants cuffs (4, 6, or 8 chambers) designed to simulate kneading and stroking of tissue. It is intended to temporarily relieve minor muscle aches and pains and temporarily increase circulation in healthy adults, for use in clinical, athletic, and home settings.

The proposed devices feature a control unit with sequential compression technology, Bluetooth connectivity enabling mobile app control (iOS and Android), upgraded software (versions 1.5–3.8), and optional cloud data storage via Amazon Cognito. The predicate device had no Bluetooth or mobile app capability. Both use microprocessor control, compressor-valve systems, nylon cuffs, and ABS enclosures with 16 pressure levels and adjustable treatment parameters (5–99 minutes).

IEC 60601-1 (general safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-11 (medical electrical equipment safety), IEC 62133-2 (lithium-ion battery compliance), IEC 62304 (software lifecycle processes), FCC 47 CFR 15.247 (RF emissions), ANSI C63.27 (wireless coexistence), and cybersecurity testing per FDA guidance issued June 27, 2025.

The proposed devices are substantially equivalent to the predicate (VU-IPC04B) because they share identical intended use, classification, regulation, and core sequential compression technology. Minor design differences (power source, control unit size, cuff dimensions, chamber count, weight) do not affect safety or effectiveness as both comply with the same electrical safety standards. The Bluetooth and software upgrades have been validated per IEC 62304 and FCC/RF standards, with cybersecurity testing demonstrating the device is safe and reliable.