# K214037: Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac

- Pathway: 510(k) (Traditional)
- Applicant: Ergo-Flex Technologies, LLC
- Decided: Feb 22, 2024 after 791 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K894435 (1989). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053223: Triton/Tru-Trac/TX/Triton DTS Traction, Chattanooga Group (2006) Summary page 10.

## Indications for use
The Back on Trac (BOTGEN1) and Cervi-Trac Systems are intended for use in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder). Back on Trac The Back on Trac (BOTGEN1) is intended for use to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder)”. The device may be used to manage and reduce pain associated with the following conditions: • facet syndrome, • herniated disc, • protruding disc, • extruded disc, • sciatica, • spondylosis (degenerative disc disease & facet syndrome), • joint pain. Vibration and heat are available options that can be utilized with the Back on Trac (BOTGEN1) at the discretion of the healthcare professional. When activated, the vibration mode can provide muscle relaxation and temporary relief of minor aches and pains. The heat mode, when activated, can provide temporary relief of minor aches and pains. The local warmth temporarily stimulates local blood circulation in your lower back. Cervi-Trac The Cervi-Trac is intended for use as an accessory to the Back on Trac (BOTGEN1) to relieve pressures on structures that may be causing pain of skeletal or muscular origin. The Cervi-Trac accessory focuses specifically on the cervical region.

Source page: https://510kreport.com/device/K214037
Methodology: https://510kreport.com/methodology