Lo-Bak Trax
FDA 510(k) K110858 · Roland F Berthiaume, DC
510(k) numberK110858
Submission
- Device name
- Lo-Bak Trax
- Applicant
- Roland F Berthiaume, DC
Springfield, MA, US - Received
- March 28, 2011
- Decision date
- August 2, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HST – Apparatus, Traction, Non-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5850
- Specialty
- Orthopedic
Other 510(k)s with product code HST
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162702 | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation…HST · Traditional | Stl International, Inc. | 12/30/2016SE |
| K984190 | Back-On-Trac, Model 101BOTHST · Traditional | Back-On-Track, Inc. | 03/15/1999SE |
| K872121 | K and D Home TractHST · Traditional | Joseph A. Kott, M.D. | 08/12/1987SE |
| K870212 | Arthroscopic Shoulder HolderHST · Traditional | Dyonics, Inc. | 02/20/1987SE |
| K870125 | Extremity ElevatorHST · Traditional | Orthopedic Systems, Inc. | 02/04/1987SE |
| K870102 | Tupper TrolleyHST · Traditional | Orthopedic Systems, Inc. | 02/03/1987SE |
| K864765 | Model 668, Traction Splint, AdultHST · Traditional | Ferno-Washington, Inc. | 12/17/1986SE |
| K862874 | The Towered 90/90 UnitHST · Traditional | Lossing Orthopedic, Inc. | 08/07/1986SE |
| K860037 | Suspender Orthopedic Suspension DeviceHST · Traditional | Comfortex, Inc. | 01/21/1986SE |
| K855179 | Transfer-Trax (TM) Splint TractionHST · Traditional | Comfortex, Inc. | 01/21/1986SE |
Questions and answers
When was Lo-Bak Trax cleared by the FDA?
Lo-Bak Trax (K110858) received a 510(k) decision of Substantially Equivalent on August 2, 2011, 127 days after the submission was received.
What is the product code of K110858?
The FDA product code is HST – Apparatus, Traction, Non-Powered, a Class I (low risk) device regulated under 21 CFR 888.5850.