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 |