Ferno Ille Inferno Moist Heat Therapy Ut, 916/917
FDA 510(k) K924023 · Ferno
510(k) numberK924023
Submission
- Device name
- Ferno Ille Inferno Moist Heat Therapy Ut, 916/917
- Applicant
- Ferno
Wilmington, OH, US - Received
- August 11, 1992
- Decision date
- April 14, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
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|---|---|---|---|
| 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 |
| 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 |
More from Tru-Eze Mfg. Co., Inc.
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| K932260 | Ferno-Washington Ambulance Cot, 93ES Squad-MateFPO · Traditional | 09/09/1993SE |
| K931346 | Ferno-Washington Incubator Transporter,# 29-ITFPL · Traditional | 08/25/1993SE |
| K924669 | Ferno-Washington Basket Stretcher, Model 71-WFPP · Traditional | 04/29/1993SE |
| K914125 | Ferno Ille Hi-Lo Jr. Mobile Whirlpool, Model 403ILJ · Traditional | 10/25/1991SE |
Questions and answers
When was Ferno Ille Inferno Moist Heat Therapy Ut, 916/917 cleared by the FDA?
Ferno Ille Inferno Moist Heat Therapy Ut, 916/917 (K924023) received a 510(k) decision of Substantially Equivalent on April 14, 1993, 246 days after the submission was received.
What is the product code of K924023?
The FDA product code is IRQ – Unit, Heating, Powered, a Class I (low risk) device regulated under 21 CFR 890.5950.