Polar Care Wave
FDA 510(k) K183702 · Breg, Inc.
510(k) numberK183702
Submission
- Device name
- Polar Care Wave
- Applicant
- Breg, Inc.
Carlsbad, CA, US - Received
- December 31, 2018
- Decision date
- March 1, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IRP – Massager, Powered Inflatable Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5650
- Specialty
- Physical Medicine
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| K251622 | Hand Massager (SM004D)IRP · Traditional | Ningbo Zhenhai Yihao Electronic Technology Co.… | 01/28/2026SE |
More from Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K961855 | Polar Care (Model 500/50000)ILO · Traditional | 08/09/1996SE |
Questions and answers
When was Polar Care Wave cleared by the FDA?
Polar Care Wave (K183702) received a 510(k) decision of Substantially Equivalent on March 1, 2019, 60 days after the submission was received.
What is the product code of K183702?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.