DR Kool
FDA 510(k) K935841 · Toronto Medical Corp.
510(k) numberK935841
Submission
- Device name
- DR Kool
- Applicant
- Toronto Medical Corp.
Canada L1w2y5, CA - Received
- December 7, 1993
- Decision date
- August 29, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5720
- Specialty
- Physical Medicine
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| K213097 | Armory MotionILO · Traditional | Pain Management Technologies, Inc. | 06/10/2022SE |
| K083008 | CoolskinILO · Abbreviated | Elbio Co., Ltd. | 06/10/2009SE |
| K073675 | T-Pump Localized Temperature Therapy PumpILO · Traditional | Gaymar Industries, Inc. | 05/08/2008SE |
| K072152 | Juniper CLN1 Dermal Cooling DeviceILO · Traditional | Juniper Medical, Inc. | 09/07/2007SE |
| K070402 | Modification to Polar Care 500ILO · Special | Breg, Inc. | 03/29/2007SE |
| K040317 | Ivc SystemILO · Traditional | Mark H. Friedman | 05/07/2004SE |
| K973023 | Incare Hot/Ice System Foot/Ankle BlanketILO · Traditional | Hollister, Inc. | 11/03/1997SE |
| K970197 | HTP-1500 Localized Heat Therapy PumpILO · Traditional | Adroit Medical Systems, Inc. | 09/10/1997SE |
| K964799 | Artrotherm Cryotherapy and ThernotherapyILO · Traditional | Ormed GmbH | 08/29/1997SE |
| K964354 | Artocool-S Water Circulating Cold PackILO · Traditional | Ormed GmbH | 08/29/1997SE |
More from Ormed GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K950682 | W2 Wrist CPM UnitBXB · Traditional | 09/13/1995SE |
| K945121 | A3 Ankle CPM UnitBXB · Traditional | 02/17/1995SE |
| K935587 | Multilink Shoulder CPM UnitBXB · Traditional | 12/14/1994SE |
| K935808 | Revolution Lower Limb CPM UnitBXB · Traditional | 03/18/1994SE |
| K925926 | Mobilimb T1 Toe CPM UnitBXB · Traditional | 03/22/1993SE |
| K900795 | Mobilimb L4 Lower Limb CPM UnitBXB · Traditional | 03/12/1990SE |
| K900466 | Mobilimb W1 Wrist CPM UnitBXB · Traditional | 03/12/1990SE |
| K900794 | Mobilimb H3 Hand CPM UnitJFA · Traditional | 03/02/1990SE |
| K895720 | Mobilimb J1 TMJ CPM UnitBXB · Traditional | 01/04/1990SE |
| K891345 | Mobilimb CPM Shoulder UnitBXB · Traditional | 04/24/1989SE |
Questions and answers
When was DR Kool cleared by the FDA?
DR Kool (K935841) received a 510(k) decision of Substantially Equivalent for Some Indications on August 29, 1994, 265 days after the submission was received.
What is the product code of K935841?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.