Normatec Elite Hip

The Normatec Elite Hip is a powered inflatable tube massager designed to temporarily relieve minor muscle aches and pains and increase circulation in the hip area. It uses sequential inflation of two inflatable segments controlled by a microprocessor, with user control via buttons or Bluetooth app, and operates on a rechargeable lithium-ion battery plus external power supply.

The device uses a compressor and valve system with sequential gradient, peristaltic, and pulsing inflation cycles. It features 7 adjustable pressure levels (0–110 mm Hg), adjustable treatment time (15–60 minutes), a 200 denier nylon contact surface with polyurethane laminate, and Bluetooth capability. The key difference from the predicate is the hip attachment with 2 inflatable segments instead of the predicate's 5-segment leg attachment, and software modifications to disable RF synchronous function and alter the solenoid algorithm for 2 instead of 5 segments.

AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, ANSI C63.27-2017, and IEC 62133-2 (lithium-ion battery compliance).

The subject device is substantially equivalent because it has identical indications for use, intended environment (clinics, home, athletic settings), and patient population (adults) as the predicate Normatec Elite. Although the hip attachment differs anatomically from the predicate's leg attachment, the reference device Normatec 3 already cleared by FDA demonstrates that hip attachments using the same underlying compressor-valve technology are safe and effective. The software modifications (RF disabling and solenoid algorithm adjustment for 2 segments) are minor alterations to previously cleared functions, and bench testing confirms performance metrics are consistent with the predicate and within acceptance criteria.