Pulsair Model SP-1
FDA 510(k) K832177 · Thermowave Medical Device Corp.
510(k) numberK832177
Submission
- Device name
- Pulsair Model SP-1
- Applicant
- Thermowave Medical Device Corp.
Walker, MI, US - Received
- July 6, 1983
- Decision date
- December 9, 1983
- 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 |
| 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 |
| K801625 | Thermolator Heating UnitIRQ · Traditional | Tru-Eze Mfg. Co., Inc. | 07/28/1980SE |
Questions and answers
When was Pulsair Model SP-1 cleared by the FDA?
Pulsair Model SP-1 (K832177) received a 510(k) decision of Substantially Equivalent on December 9, 1983, 156 days after the submission was received.
What is the product code of K832177?
The FDA product code is IRQ – Unit, Heating, Powered, a Class I (low risk) device regulated under 21 CFR 890.5950.