Cold/Hot Fluid Radiation Pad Neutech
FDA 510(k) K893706 · Burke, Inc.
510(k) numberK893706
Submission
- Device name
- Cold/Hot Fluid Radiation Pad Neutech
- Applicant
- Burke, Inc.
Largo, FL, US - Received
- May 18, 1989
- Decision date
- June 22, 1989
- 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
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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 |
| K964354 | Artocool-S Water Circulating Cold PackILO · Traditional | Ormed GmbH | 08/29/1997SE |
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| K061912 | FusionINI · Traditional | 08/01/2006SE |
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| K982158 | ScoutITI · Traditional | 08/31/1998SE |
| K965123 | Pace Saver, Little Junior (Modification)(Motorized Three-Wheeled Vehicle)INI · Traditional | 07/17/1997SE |
| K911943 | Concept Model 5200 Thermal Therapy SystemILO · Traditional | 07/19/1991SE |
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Questions and answers
When was Cold/Hot Fluid Radiation Pad Neutech cleared by the FDA?
Cold/Hot Fluid Radiation Pad Neutech (K893706) received a 510(k) decision of Substantially Equivalent on June 22, 1989, 35 days after the submission was received.
What is the product code of K893706?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.