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FDA 510(k)

WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES

K-Number: K080465 · 2008-07-18

ApplicantWs Far IR Medical Technology Co., Ltd.
Decision Date2008-07-18
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Ws Far IR Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2008-07-18 under 510(k) number K080465. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES?

WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES is a medical device that received FDA 510(k) clearance on 2008-07-18. The listed applicant is Ws Far IR Medical Technology Co., Ltd.. The 510(k) number is K080465.

When did WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES receive FDA 510(k) clearance?

WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES received FDA 510(k) clearance on 2008-07-18, under 510(k) number K080465.

Who is the listed applicant for WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES?

The FDA 510(k) record lists Ws Far IR Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES?

The FDA product code for WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES is ILY.

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Other records listing Ws Far IR Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: ILY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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