Thermocool System
FDA 510(k) K950395 · Zimmer, Inc.
510(k) numberK950395
Submission
- Device name
- Thermocool System
- Applicant
- Zimmer, Inc.
Dover, OH, US - Received
- February 1, 1995
- Decision date
- August 18, 1995
- 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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| 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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Questions and answers
When was Thermocool System cleared by the FDA?
Thermocool System (K950395) received a 510(k) decision of Substantially Equivalent for Some Indications on August 18, 1995, 198 days after the submission was received.
What is the product code of K950395?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.