Delta Therm Cold Therapy System
FDA 510(k) K945399 · Deltatherm
510(k) numberK945399
Submission
- Device name
- Delta Therm Cold Therapy System
- Applicant
- Deltatherm
Pittsburgh, PA, US - Received
- November 4, 1994
- Decision date
- March 7, 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
Other 510(k)s with product code ILO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was Delta Therm Cold Therapy System cleared by the FDA?
Delta Therm Cold Therapy System (K945399) received a 510(k) decision of Substantially Equivalent for Some Indications on March 7, 1995, 123 days after the submission was received.
What is the product code of K945399?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.