Thermolator Heating Unit

FDA 510(k) K801625 · Tru-Eze Mfg. Co., Inc.

Substantially Equivalent

510(k) numberK801625

Submission

Device name
Thermolator Heating Unit
Applicant
Tru-Eze Mfg. Co., Inc.
Mchenry, IL, US
Received
July 15, 1980
Decision date
July 28, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IRQ – Unit, Heating, Powered
Device class
Class I (low risk)
Regulation
21 CFR 890.5950
Specialty
Physical Medicine

Other 510(k)s with product code IRQ

510(k)DeviceApplicantDecision
K050524Ez-Iv Medical Pad Warming Unit, Model 1000IRQ · Traditional Marda Medical, Inc.09/14/2005SE
K950350Themalator. Models T-4-S, T-8-S, Etc.IRQ · Traditional Whitehall/Div Columbus Mckennon Corp.03/24/1995SE
K924023Ferno Ille Inferno Moist Heat Therapy Ut, 916/917IRQ · Traditional Ferno04/14/1993SE
K880644Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional Fred Sammons, Inc.05/06/1988SE
K861340R1750 and R1424 Powered Heating UnitsIRQ · Traditional Tri W-G, Inc.05/02/1986SE
K832177Pulsair Model SP-1IRQ · Traditional Thermowave Medical Device Corp.12/09/1983SE

More from Thermowave Medical Device Corp.

510(k)DeviceDecision
K800917Tru-Cold Therapy PakIME · Traditional 05/02/1980SE
K791653Reusable Moist Heat PackIMA · Traditional 09/07/1979SE

Questions and answers

When was Thermolator Heating Unit cleared by the FDA?

Thermolator Heating Unit (K801625) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 13 days after the submission was received.

What is the product code of K801625?

The FDA product code is IRQ – Unit, Heating, Powered, a Class I (low risk) device regulated under 21 CFR 890.5950.