Polar Care Wave
Massager, Powered Inflatable Tube
Breg Inc.
The following data is part of a premarket notification filed by Breg Inc. with the FDA for Polar Care Wave.
Pre-market Notification Details
| Device ID | K183702 |
| 510k Number | K183702 |
| Device Name: | Polar Care Wave |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Breg Inc. 2885 Locker Ave. East Carlsbad, CA 92010 |
| Contact | Monique Zamora |
| Correspondent | Monique Zamora Breg Inc. 2885 Locker Ave. East Carlsbad, CA 92010 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-31 |
| Decision Date | 2019-03-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00672736134030 | K183702 | 000 |
| 00672736133996 | K183702 | 000 |
| 00672736133989 | K183702 | 000 |
| 00672736134023 | K183702 | 000 |
| 00672736134016 | K183702 | 000 |
| 00672736134009 | K183702 | 000 |
Trademark Results [Polar Care Wave]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLAR CARE WAVE 87505956 5868880 Live/Registered |
Breg, Inc. 2017-06-26 |
 POLAR CARE WAVE 86288230 not registered Dead/Abandoned |
Breg, Inc. 2014-05-21 |
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