# K984190: Back-on-Trac, Model 101BOT

- Pathway: 510(k) (Traditional)
- Applicant: Back-On-Track, Inc.
- Decided: Mar 15, 1999 after 112 days
- Product code: HST (Apparatus, Traction, Non-Powered)
- Device class: 1
- Regulation: 21 CFR 888.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The BACK-ON-TRAC is intended for the treatment of acute and chronic low back pain of disc origin or due to malalignments of the apophyseal joints.

Source page: https://510kreport.com/device/K984190
Methodology: https://510kreport.com/methodology