Arthritic Heat Wrap
FDA 510(k) K925820 · Conair Corp.
510(k) numberK925820
Submission
- Device name
- Arthritic Heat Wrap
- Applicant
- Conair Corp.
Stamford, CT, US - Received
- November 17, 1992
- Decision date
- February 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IRT – Pad, Heating, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5740
- Specialty
- Physical Medicine
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| K142228 | Heated Eye PadIRT · Traditional | Digital Heat Corporation | 02/09/2015SE |
| K133981 | Avacen 100IRT · Abbreviated | Avacen, Inc. | 08/15/2014SE |
| K111273 | Fir Heat Theraphy SysyemsIRT · Traditional | Shenzhen Anpan Technology Co., Ltd. | 11/08/2011SE |
| K072534 | Bio-Mat 2000IRT · Traditional | Richway Intl., Inc. | 02/08/2008SE |
| K963887 | Pt-Pac Portable Heating PadIRT · Traditional | Anthony A. Chiurco | 03/31/1997SE |
| K963824 | Li's Itch StopperIRT · Traditional | Hontech Foundation For Medical Technology | 12/12/1996SE |
| K962195 | Health O Meter Electric Heating Pads Models EHP2, EHP3IRT · Traditional | Sunbeam Health Division | 11/27/1996SE |
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| K942950 | Body FlexISA · Traditional | 07/26/1994SN |
| K942223 | Body SystemISA · Traditional | 06/09/1994SN |
| K940369 | Body RechargerISA · Traditional | 04/21/1994SN |
Questions and answers
When was Arthritic Heat Wrap cleared by the FDA?
Arthritic Heat Wrap (K925820) received a 510(k) decision of Substantially Equivalent on February 2, 1994, 442 days after the submission was received.
What is the product code of K925820?
The FDA product code is IRT – Pad, Heating, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5740.