WS Far Infrared Therapy Unit TY-101F

by Ws Far IR Medical Technology Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04719873220045 UDI-DI	Date1 Nov 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: WS Far Infrared Therapy Unit
Generic Name: Full-body radiant heating system
Model / Reference: TY-101F

Primary DI / UDI-DI: 04719873220045
510(k) Number: K080465
FDA Product Code: ILY
GMDN Term: Full-body radiant heating system

Device Class: Class II
Regulation Number: 890.5500
GUDID distribution status: In Commercial Distribution

Other devices from Ws Far IR Medical Technology Co., Ltd.

WS Far Infrared Therapy Unit KP-B210

Class II
Ws Far Infrared Therapy Unit, Model # Ty-101 Series

Class II
WS(TM) Far-Infrared Therapy Unit, Model KP-B210

Class II

Properties

Prescription Use
Over-the-Counter
Serial Number
Manufacturing Date

Other properties (10)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No