Ultra-Pan for Orthotic Plastics (7262)
FDA 510(k) K880644 · Fred Sammons, Inc.
510(k) numberK880644
Submission
- Device name
- Ultra-Pan for Orthotic Plastics (7262)
- Applicant
- Fred Sammons, Inc.
Burr Ridge, IL, US - Received
- February 16, 1988
- Decision date
- May 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | 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 |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | 04/01/1988SE |
| K831549 | Arm SlingsILI · Traditional | 06/30/1983SE |
| K831548 | SplintsILH · Traditional | 06/27/1983SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | 06/24/1983SE |
| K831543 | Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional | 06/24/1983SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
| K831552 | Sorbothane Visco Inner Sole PadKNP · Traditional | 06/08/1983SE |
| K831547 | Raised Toilet Seats & Nail ClippersILS · Traditional | 06/08/1983SE |
Questions and answers
When was Ultra-Pan for Orthotic Plastics (7262) cleared by the FDA?
Ultra-Pan for Orthotic Plastics (7262) (K880644) received a 510(k) decision of Substantially Equivalent on May 6, 1988, 80 days after the submission was received.
What is the product code of K880644?
The FDA product code is IRQ – Unit, Heating, Powered, a Class I (low risk) device regulated under 21 CFR 890.5950.