Unit, Heating, Powered
FDA product code IRQ · Class I (low risk) · 21 CFR 890.5950 · Physical Medicine
7510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050524 | Ez-Iv Medical Pad Warming Unit, Model 1000IRQ · Traditional | Marda Medical, Inc. | 09/14/2005SE |
| K950350 | Themalator. Models T-4-S, T-8-S, Etc.IRQ · Traditional | Whitehall/Div Columbus Mckennon Corp. | 03/24/1995SE |
| K924023 | Ferno Ille Inferno Moist Heat Therapy Ut, 916/917IRQ · Traditional | Ferno | 04/14/1993SE |
| K880644 | Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional | Fred Sammons, Inc. | 05/06/1988SE |
| K861340 | R1750 and R1424 Powered Heating UnitsIRQ · Traditional | Tri W-G, Inc. | 05/02/1986SE |
| K832177 | Pulsair Model SP-1IRQ · Traditional | Thermowave Medical Device Corp. | 12/09/1983SE |
| K801625 | Thermolator Heating UnitIRQ · Traditional | Tru-Eze Mfg. Co., Inc. | 07/28/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1323-2012 | The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device.…On 11/15/2011 Biomet Microfixation, Jacksonville, FL initiated a recall of their Acticort Heat/Contouring… | Biomet Microfixation, LLC | 11/15/2011Terminated |