ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)

The Heat Exchange Equipment for Cryotherapy and Thermotherapy (Z-ONE, ZT Cube, ZT Clinic) provides combined cold, heat, contrast, and compression therapies for post-surgical and trauma injuries to reduce edema, swelling, and pain. The devices are AC-powered, software-controlled units intended for use by licensed health care professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.

All three models feature touchscreen interfaces, AC power, and deliver compression (15–80 mmHg in four levels), cold therapy (5–90 minutes), heat therapy (5–30 minutes), and contrast therapy. Z-ONE is portable and cold-only (41°F–59°F); ZT Cube is portable with full modalities (34°F–104°F) and connects up to 2 wraps; ZT Clinic is wheeled and larger (34°F–113°F) with capacity for up to 4 wraps. Subject devices use a single reservoir with NON-TOX cooling glycol; the predicate (Med4 Elite) uses separate heat and cold reservoirs with distilled water and different chilling/heating mechanisms.

IEC 60601-1 Edition 3.2, ANSI AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2 Edition 4.1, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-12:2021, ISO 10993-23:2021. Additionally, devices were tested per the FDA Guidance Document for Heating and Cooling Devices (July 26, 1995) for skin temperature in worst-case scenarios.

The devices are substantially equivalent because they employ identical technical principles—delivering localized heat exchange and intermittent pneumatic compression therapy—with the same indications for use, intended users (licensed professionals), and clinical settings. Although mechanical differences exist (single vs. dual reservoirs, different coolant types, refrigeration vs. resistance heating), the manufacturer demonstrates that each design achieves its intended performance specifications and temperature ranges. The predicate Game Ready GRPro 2.1 System (K192114) is referenced for lowest temperature and cryotherapy duration, confirming these parameters are safe and accepted. Performance testing (temperature accuracy, pressure accuracy, wrap seam strength, durability over 200 cycles) and biocompatibility evaluation (ISO 10993) of the polyether polyurethane wrap material establish that no new safety or effectiveness issues arise from the technological and material differences.