FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Polar Care Wave
K Number: K183702
·
Decision Mar 1, 2019
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
152
Applicant Total
16
Review Days
60
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Basic Information
- Device Name
- Polar Care Wave
- K Number
- K183702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5650
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Breg, Inc.
- Date Received
- December 31, 2018
- Decision Date
- March 1, 2019
- Product Code
- IRP
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | FDA class 2 | Physical Medicine |
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Other Clearances by Breg, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070402 | MODIFICATION TO POLAR CARE 500 | Mar 29, 2007 | Substantially Equivalent |
| K041714 | E-PAIN CARE | Oct 1, 2004 | Substantially Equivalent |
| K020988 | PAIN CARE 4200 | Apr 4, 2002 | Substantially Equivalent |
| K013928 | PAIN CARE 3200 | Dec 3, 2001 | Substantially Equivalent |
| K003611 | PAIN CARE MULTI-PORT CATHETER, MODEL 2000L | Dec 13, 2000 | Substantially Equivalent |
| K002073 | PAIN CARE 3000 | Sep 19, 2000 | Substantially Equivalent |
| K002321 | PAIN CARE 2000L | Aug 14, 2000 | Substantially Equivalent |
| K983454 | PAIN CARE 2000 | Dec 16, 1998 | Substantially Equivalent |
| K963596 | POLAR CARE 300 | Dec 4, 1996 | Substantially Equivalent |
| K961855 | POLAR CARE (MODEL 500/50000) | Aug 9, 1996 | Substantially Equivalent |