The following data is part of a premarket notification filed by Winback Usa Corp with the FDA for Winback Back 3se.
| Device ID | K162828 |
| 510k Number | K162828 |
| Device Name: | Winback Back 3SE |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | WINBACK USA CORP 302 HIGH PLAINS DR Dripping Springs, TX 78620 |
| Contact | Cheick Kongo |
| Correspondent | David Furr FDC SERVICES 8708 CAPEHART COVE Austin, TX 78733 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-07 |
| Decision Date | 2017-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800092010855 | K162828 | 000 |