510(k) Report

510(k) · Cleared

Cleared

Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table

K162702510(k) TraditionalCleared Dec 30, 201693-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

Stl International, Inc. · HST Apparatus, Traction, Non-Powered

Cleared on Dec 30, 2016 as substantially equivalent to K110858 (Roland F Berthiaume, DC, 2011) after a 93-day review. Its family tree reaches back 1 generation to 2011.

Decided
Dec 30, 2016
Review
93 days
Class
Class I
Product code
HST
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K110858 (2011). No later device cites it as a predicate yet.

K110858 · LO-Bak Trax · Roland F Berthiaume, DC · 201120102012201420162018
K110858 · LO-Bak Trax · Roland F Berthiaume, DC · 20110
  1. Root · 1 generation backK110858 LO-Bak TraxRoland F Berthiaume, DC · 2011
  2. This deviceK162702 Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward…Stl International, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K110858LO-Bak TraxRoland F Berthiaume, DC2011—
0 (this device)K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation…Stl International, Inc.2016—
FIG. 1 — Lineage of K162702, 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
*K110858LO-Bak Trax
Summary page 4
…Code: HST Class: I III. PREDICATE DEVICE Predicate Device Lo-Bak TRAK, K110858 This predicate device has not been subject to a recall. IV. DEVICE DESCRIPTION Teeter’s decom…
Roland F Berthiaume, DC2011—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.

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. 2016, 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?

Teeter Decompression Devices are multiple user, reusable devices for home use, intended to provide traction to the spine while stretching the para-spinal muscles and soft tissues. The devices provide non-powered traction and are meant for use by adults.

Use of the Teeter Decompression Devices is indicated for the following conditions: back pain, muscle tension, degenerative disc disease, spinal degenerative joint disease, spinal stenosis, herniated disc, spinal curvature due to tight muscles, sciatica, muscle spasm, and facet syndrome.

Indications for use as stated in the FDA summary.

Recent decisions in HST

The HST category page

  • K110858LO-Bak TraxRoland F Berthiaume, DC · 2011
  • 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/K162702 · printed Nov 5, 2026

Cite this page

510(k) Report. “K162702: Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162702

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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