Product code IRQ— Physical Medicine

FDA has cleared 7 devices under product code IRQ between 1980 and 2005, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20051 clearance
• 19951 clearance
• 19931 clearance
• 19881 clearance
• 19861 clearance
• 19831 clearance
• 19801 clearance

• Whitehall/Div Columbus Mckennon Corp.1 clearance
• Tru-Eze Mfg. Co., Inc.1 clearance
• Tri W-G, Inc.1 clearance
• Thermowave Medical Device Corp.1 clearance
• Marda Medical, Inc.1 clearance
• Fred Sammons, Inc.1 clearance
• Ferno1 clearance

• K050524 — EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000Marda Medical, Inc.·2005-09-14
• K950350 — THEMALATOR. MODELS T-4-S, T-8-S, ETC.Whitehall/Div Columbus Mckennon Corp.·1995-03-24
• K924023 — FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917Ferno·1993-04-14
• K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)Fred Sammons, Inc.·1988-05-06
• K861340 — R1750 AND R1424 POWERED HEATING UNITSTri W-G, Inc.·1986-05-02
• K832177 — PULSAIR MODEL SP-1Thermowave Medical Device Corp.·1983-12-09
• K801625 — THERMOLATOR HEATING UNITTru-Eze Mfg. Co., Inc.·1980-07-28