Infrarax Device

510(k) Number

K850852 ↗

FDA product code

ILY

Device class

Class II

Regulation

21 CFR Part 890.5500

Advisory committee

Physical Medicine

FDA decision

SESE Substantially Equivalent

Other devices filed under FDA product code ILY (Lamp, Infrared, Therapeutic Heating).

• WARP10, WARP75 by Quantum Devices, Inc.
• WS-501 Heat Lamp by Lhasa Medical, Inc.
• ASA LASER SH1 by El.En Electronic Engineering Spa
• SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) by Cure Point Therapeutics, Inc.
• QK-Wide Band Spectrum Therapeutic Apparatus, Models CO1A, CO1B, CO1C, CO1D, CO2A, CO2B by United Pacific Co., Ltd.
• Yolo Curve by Yolo Medical, Inc.
• Infravib Massager Model PR-1000 by Infralux International, Inc.
• Lumina 1600, 3300 and 6600 Systems by Usa Laser Biotech, Inc.
• DPL Therapy System by LED TECHNOLOGIES, INC.
• ST-302 Infrarex by Skylark Device Co., Ltd.

• Shoe Covers

  Class I

  FDA 510(k) K844705 Active Cleared 10 Jan 1985

• Cleane

  Class II

  FDA 510(k) K111341 Active Cleared 29 Feb 2012 GUDID on market

• Wheelchairs

  Class I

  FDA 510(k) K844574 Active Cleared 21 Feb 1985

• Caps (O.R. Nurse, Surgical)

  Class I

  FDA 510(k) K844704 Active Cleared 10 Jan 1985

See all devices from Medicon Co., Ltd. →