Polar Care (Model 500/50000)
FDA 510(k) K961855 · Breg, Inc.
510(k) numberK961855
Submission
- Device name
- Polar Care (Model 500/50000)
- Applicant
- Breg, Inc.
Vista, CA, US - Received
- May 14, 1996
- Decision date
- August 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
| 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 |
More from Ormed GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K183702 | Polar Care WaveIRP · Traditional | 03/01/2019SE |
| K070402 | Modification to Polar Care 500ILO · Special | 03/29/2007SE |
| K041714 | E-Pain CareFRN · Traditional | 10/01/2004SE |
| K020988 | Pain Care 4200MEB · Special | 04/04/2002SE |
| K013928 | Pain Care 3200MEB · Special | 12/03/2001SE |
| K003611 | Pain Care Multi-Port Catheter, Model 2000LFRN · Special | 12/13/2000SE |
| K002073 | Pain Care 3000MEB · Traditional | 09/19/2000SE |
| K002321 | Pain Care 2000LMEB · Special | 08/14/2000SE |
| K983454 | Pain Care 2000MEB · Traditional | 12/16/1998SE |
| K963596 | Polar Care 300ILO · Traditional | 12/04/1996SE |
Questions and answers
When was Polar Care (Model 500/50000) cleared by the FDA?
Polar Care (Model 500/50000) (K961855) received a 510(k) decision of Substantially Equivalent on August 9, 1996, 87 days after the submission was received.
What is the product code of K961855?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.