Hydro-Thero Pad
FDA 510(k) K841697 · Maddak, Inc.
510(k) numberK841697
Submission
- Device name
- Hydro-Thero Pad
- Applicant
- Maddak, Inc.
Mchenry, IL, US - Received
- April 23, 1984
- Decision date
- May 9, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K250047 | bite away twoIRT · Traditional | mibeTec GmbH | 09/12/2025SE |
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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 |
More from Sunbeam Health Division
| 510(k) | Device | Decision |
|---|---|---|
| K841700 | Walk & RollINM · Traditional | 05/11/1984SE |
| K841698 | Heat PackIMA · Traditional | 05/10/1984SE |
| K841695 | CrawlerKNL · Traditional | 05/10/1984SE |
| K841693 | Standing Frame · Traditional | 05/09/1984SE |
| K841692 | Prone Stander · Traditional | 05/09/1984SE |
| K841691 | Split Seat Positioning ChairINN · Traditional | 05/09/1984SE |
| K834311 | Night TrainerKPN · Traditional | 03/30/1984SE |
| K833870 | Knee WalkerION · Traditional | 11/29/1983SE |
| K833177 | Glossectomy Feeding SpoonsILC · Traditional | 10/31/1983SE |
| K833090 | Sensory Roller MassagerISA · Traditional | 10/14/1983SE |
Questions and answers
When was Hydro-Thero Pad cleared by the FDA?
Hydro-Thero Pad (K841697) received a 510(k) decision of Substantially Equivalent on May 9, 1984, 16 days after the submission was received.
What is the product code of K841697?
The FDA product code is IRT – Pad, Heating, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5740.