IRQ · Unit, Heating, Powered
Physical Medicine · 21 CFR 890.5950 · Class 1
Overview
| Product Code | IRQ |
|---|---|
| Device Name | Unit, Heating, Powered |
| Regulation | 21 CFR 890.5950 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A powered heating unit 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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050524 | EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 | Marda Medical, Inc. | Sep 14, 2005 | SESE |
| K950350 | THEMALATOR. MODELS T-4-S, T-8-S, ETC. | Whitehall/Div Columbus Mckennon Corp. | Mar 24, 1995 | SESE |
| K924023 | FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 | Ferno | Apr 14, 1993 | SESE |
| K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | Fred Sammons, Inc. | May 6, 1988 | SESE |
| K861340 | R1750 AND R1424 POWERED HEATING UNITS | Tri W-G, Inc. | May 2, 1986 | SESE |
| K832177 | PULSAIR MODEL SP-1 | Thermowave Medical Device Corp. | Dec 9, 1983 | SESE |
| K801625 | THERMOLATOR HEATING UNIT | Tru-Eze Mfg. Co., Inc. | Jul 28, 1980 | SESE |
Top Applicants
- Ferno — 1 clearance
- Fred Sammons, Inc. — 1 clearance
- Marda Medical, Inc. — 1 clearance
- Thermowave Medical Device Corp. — 1 clearance
- Tri W-G, Inc. — 1 clearance
