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Relief Pak 24 pack heating Unit mobile

KARIS Co.,Ltd · Model 11-1986 · UDI-DI 08809520550574

IRQ
7
510(k) clearances
38
Adverse events
1
Recalls
48
Facilities

Description

It is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.

Recalls

DateFirmReason
2011-11-15Biomet Microfixation, LLCOn 11/15/2011 Biomet Microfixation, Jacksonville, FL initiated a recall of their Acticort Heat/Contouring Pen, Model #915-3100, Lot #861200. Product is incorrectly labeled

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.