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510(k) K160849

WS(TM) Far-Infrared Therapy Unit, Model KP-B210 by Ws Far IR Medical Technology Co., Ltd. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2016
Date Received
March 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

Other clearances by Ws Far IR Medical Technology Co., Ltd.

  • K080465 — WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES (July 18, 2008)

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