510(k) Report

510(k) · Cleared

Cleared

LO-Bak Trax

K110858510(k) TraditionalCleared Aug 2, 2011127-day reviewClass I21 CFR 888.5850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roland F Berthiaume, DC · HST Apparatus, Traction, Non-Powered

Cleared on Aug 2, 2011 after a 127-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided
Aug 2, 2011
Review
127 days
Class
Class I
Product code
HST
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2010201520202025
  1. This deviceK110858 LO-Bak TraxRoland F Berthiaume, DC · 2011
  2. Descendant · cites it directly · 0 of its ownK162702 Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward…Stl International, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation…Stl International, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K110858LO-Bak TraxRoland F Berthiaume, DC2011—
+1K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation…Stl International, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K110858, 2011–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Teeter Hang Up's Inversion Table, Model #tEP550
Named without a submission number
—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation…Stl International, Inc.20160

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K162702 (Stl International, Inc., 2016) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HST devices

HST Apparatus, Traction, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · HST

1in 2016

2011: 12016: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HST

Too few HST 510(k)s in any year since 2007 to give a median.

Recalls per year · HST

1in 2016

2009: 22013: 12014: 22016: 1
2007high 2 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HST

20in 2025

2007: 12008: 42009: 282010: 22011: 12012: 52013: 492014: 382015: 372016: 282017: 202018: 252019: 322020: 372021: 402022: 262023: 182024: 472025: 20
2007high 49 (2013) · low 1 (2007)2025

MAUDE reports naming product code HST, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—04
20090—228
20100—02
20111—01
20120—05
20130—149
20140—238
20150—037
20161—128
20170—020
20180—025
20190—032
20200—037
20210—040
20220—026
20230—018
20240—047
20250—020
20260—0—

What is it indicated for?

Lo-Bak TRAX is intended for single person use by adults to provide portable, non-powered traction force to the lumbar spine and to stretch and relax the para-spinal muscles and soft tissues.

Use of Lo-Bak TRAX is indicated for the following conditions: low back pain, degenerative disc disease, spinal degenerative joint disease, spinal stenosis, herniated disc, spinal curvature due to tight muscles, sciatica and muscle spasm.

Indications for use as stated in the FDA summary.

Recent decisions in HST

The HST category page

  • K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter…Stl International, Inc. · 2016
  • K984190Back-on-Trac, Model 101BOTBack-On-Track, Inc. · 1999
  • K872121K and D Home TractJoseph A. Kott, M.D. · 1987
  • K870212Arthroscopic Shoulder HolderDyonics, Inc. · 1987
  • K870125Extremity ElevatorOrthopedic Systems, Inc. · 1987

https://510kreport.com/device/K110858 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110858: LO-Bak Trax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110858

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026