Dual-Temp(Tm) Cooling/Warming Unit
FDA 510(k) K882310 · Seabrook Medical Systems, Inc.
510(k) numberK882310
Submission
- Device name
- Dual-Temp(Tm) Cooling/Warming Unit
- Applicant
- Seabrook Medical Systems, Inc.
Cincinnati, OH, US - Received
- June 3, 1988
- Decision date
- September 23, 1988
- Decision
- Substantially Equivalent (SESE)
- 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
Other 510(k)s with product code ILO
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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 |
|---|---|---|
| K952086 | Tropicair Convective Warming BlanketsDWJ · Traditional | 09/06/1995SE |
| K946196 | Tropicair Convective Waring SystemDWJ · Traditional | 09/06/1995SE |
| K931203 | Cool-AidILO · Traditional | 02/22/1994SE |
| K923104 | Tropic-AirDWJ · Traditional | 07/13/1993SE |
| K914182 | Golden Thermal(R)ILO · Traditional | 10/18/1991SE |
| K902756 | Tropi-CoolDWJ · Traditional | 10/22/1990SE |
| K902269 | Electri-Cool(Tm) Liquid-Circulat. Thermal TherapyILO · Traditional | 06/21/1990SE |
| K902268 | Pedia-Temp(Tm) Liquid-Circulating Hypo-Hypertherm.ILO · Traditional | 06/21/1990SE |
| K881322 | Mini-Temp(Tm)DWJ · Traditional | 06/22/1988SE |
| K873699 | Ecmo-Temp (TM) Blood Warming DeviceDWC · Traditional | 12/22/1987SE |
Questions and answers
When was Dual-Temp(Tm) Cooling/Warming Unit cleared by the FDA?
Dual-Temp(Tm) Cooling/Warming Unit (K882310) received a 510(k) decision of Substantially Equivalent on September 23, 1988, 112 days after the submission was received.
What is the product code of K882310?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.