The following data is part of a premarket notification filed by Gwr Medical, Llp with the FDA for O2 Boot.
| Device ID | K971507 |
| 510k Number | K971507 |
| Device Name: | O2 BOOT |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | GWR MEDICAL, LLP 124 COMMONS COURT Chadds Ford, PA 19317 |
| Contact | Joseph R Westwood |
| Correspondent | Joseph R Westwood GWR MEDICAL, LLP 124 COMMONS COURT Chadds Ford, PA 19317 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-25 |
| Decision Date | 1997-11-07 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() O2 BOOT 76384278 2736142 Live/Registered |
GWR Medical, Inc. 2002-03-19 |
![]() O2 BOOT 75257145 not registered Dead/Abandoned |
GWR Medical Inc., L.L.P. 1997-03-14 |