The following data is part of a premarket notification filed by Roland F Berthiaume, Dc with the FDA for Lo-bak Trax.
| Device ID | K110858 |
| 510k Number | K110858 |
| Device Name: | LO-BAK TRAX |
| Classification | Apparatus, Traction, Non-powered |
| Applicant | ROLAND F BERTHIAUME, DC 585 COOLEY STREET Springfield, MA 01128 |
| Contact | Roland F Berthiaume |
| Correspondent | Roland F Berthiaume ROLAND F BERTHIAUME, DC 585 COOLEY STREET Springfield, MA 01128 |
| Product Code | HST |
| CFR Regulation Number | 888.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-28 |
| Decision Date | 2011-08-02 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LO-BAK TRAX 88263206 not registered Dead/Abandoned |
Berthiaume, Roland F. 2019-01-16 |
![]() LO-BAK TRAX 87288661 not registered Dead/Abandoned |
Berthiaume, Roland F. 2017-01-04 |