Artocool-S Water Circulating Cold Pack
FDA 510(k) K964354 · Ormed GmbH
510(k) numberK964354
Submission
- Device name
- Artocool-S Water Circulating Cold Pack
- Applicant
- Ormed GmbH
Concord, CA, US - Received
- October 31, 1996
- Decision date
- August 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
Other 510(k)s with product code ILO
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| K213097 | Armory MotionILO · Traditional | Pain Management Technologies, Inc. | 06/10/2022SE |
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| 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 |
| K964710 | Bledsoe Cold ControlILO · Traditional | Med Technology, Inc. | 05/09/1997SE |
More from Med Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964799 | Artrotherm Cryotherapy and ThernotherapyILO · Traditional | 08/29/1997SE |
Questions and answers
When was Artocool-S Water Circulating Cold Pack cleared by the FDA?
Artocool-S Water Circulating Cold Pack (K964354) received a 510(k) decision of Substantially Equivalent on August 29, 1997, 302 days after the submission was received.
What is the product code of K964354?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.