WS FAR IR MEDICAL TECHNOLOGY CO., LTD.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Lamp, Infrared, Therapeutic Heating (ILY) (2)

Premarket Exempt

Clear

WS Far Infrared Therapy Unit - 04719873220045 Catalog Number :

Device Description : The WS Therapy Unit is an infrared heating system which emits topical heat to th The WS Therapy Unit is an infrared heating system which emits topical heat to the human body for therapeutic applications. It consists of an IR emitter (Emission spectrum ranges from 3~25 microns.), a control box, a supporting arm to allow for adjustment of the emitter locations, and a protection net on the emitter to prevent fire or direct touch by the user. The entire unit is mounted on the base that is easy to move. The device uses 100V as the power source. It meets the related requirement of IEC60601-1 Electrical Safety.

Device Class : 2

Duns Number: 656915154

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

WS Far Infrared Therapy Unit - 04719873220199 Catalog Number :

Device Description : The WS Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system The WS Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 μm Far-infrared energy through Far Infrared (FIR)radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.