510(k) Report

510(k) · Cleared

Cleared

Akron ATP9 Traction Machine

K992733510(k) TraditionalCleared Nov 10, 199989-day reviewClass II21 CFR 890.5900

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

Huntleigh Technology, Inc. · ITH Equipment, Traction, Powered

Cleared on Nov 10, 1999 as substantially equivalent to K834405 (Akron Medical Corp., 1984) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1984. 9 later devices descend from it.

Decided
Nov 10, 1999
Review
89 days
Class
Class II
Product code
ITH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K834405 (1984). 2 ancestors in all. 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1985: 1 other ancestor2006: 1 descendant cleared2008: 2 descendants cleared2010: 1 descendant cleared2015: 2 descendants cleared2009: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant clearedK834405 · Tec Traction Machine · Akron Medical Corp. · 198419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 7 descendants3 generations forward: 1 descendant K834405 · Tec Traction Machine · Akron Medical Corp. · 19840
  1. Root · 1 generation backK834405 Tec Traction MachineAkron Medical Corp. · 1984
  2. This deviceK992733 Akron ATP9 Traction MachineHuntleigh Technology, Inc. · 1999
  3. Descendant · cites it directly · 8 of its ownK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
  4. Descendant · 2 generations on · 1 of its ownK151640 Eltrac 471Enraf-Nonius, B.V. · 2015
  5. Descendant · 2 generations on · 0 of its ownK214037 Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024
  6. Descendant · 3 generations on · 0 of its ownK222912 c1TracZimmer Medizinsysteme GmbH · 2023
  7. Descendant · 2 generations on · 0 of its ownK150695 ModpodHollywog, LLC · 2015

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2006: 12008: 22009: 12010: 12015: 22023: 12024: 1
2006high 2 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 9 · See all
  • K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006 · cites it directly8descendants
  • K151640Eltrac 471Enraf-Nonius, B.V. · 2015 · 2 generations on1descendant
  • K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024 · 2 generations on0descendants
  • K222912c1TracZimmer Medizinsysteme GmbH · 2023 · 3 generations on0descendants
  • K150695ModpodHollywog, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K834405Tec Traction MachineAkron Medical Corp.1984—
0 (this device)K992733Akron ATP9 Traction MachineHuntleigh Technology, Inc.1999—
+1K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group2006—
+2K151640Eltrac 471Enraf-Nonius, B.V.2015—
+2K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC2024—
+3K222912c1TracZimmer Medizinsysteme GmbH2023—
+2K150695ModpodHollywog, LLC2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200820
200910
201010
201520
202310
202410
FIG. 1 — Lineage of K992733, 1984–2024Source: 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 ITH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new ITH device

  1. #1 K243775 True Non-Surgical Spinal Decompression System…score 10.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

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
*K834405Tec Traction Machine
Summary page 1
…1 Farthing Road Ipswich, Suffolk IP1 5AP United Kingdom Classification Name: Power traction equipment (21 CFR §890.5900) ITH Predicate Devices: TEC Traction Machine (K834405) ESCOTEK EST TRAC 401 (K844385) Device Description: The ATPQ traction is intended to provide traction and mobilization of lumba…
Akron Medical Corp.1984—
*K844385Escotek Est Trac 401
Summary page 1
…olk IP1 5AP United Kingdom Classification Name: Power traction equipment (21 CFR §890.5900) ITH Predicate Devices: TEC Traction Machine (K834405) ESCOTEK EST TRAC 401 (K844385) Device Description: The ATPQ traction is intended to provide traction and mobilization of lumbar and cervical muscles and vert…
Nor-Am Patient Care Products, Inc.1985—

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group20068

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K053223 (Chattanooga Group, 2006) has gone furthest, with 8 descendants of its own.

How does its category compare?

All ITH devices

ITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITH

2in 2025

2007: 22008: 42009: 12010: 12011: 12012: 12014: 22015: 22023: 12024: 12025: 2
2007high 4 (2008) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITH

132in 2008

2008: 132 days median
2007high 132 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ITH

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · ITH

3in 2025

2007: 22009: 32010: 32011: 52012: 12013: 22014: 52015: 12016: 22017: 22019: 52021: 12023: 12024: 52025: 3
2007high 5 (2011) · low 0 (2008)2025

MAUDE reports naming product code ITH, 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
20072—02
2008413200
20091—03
20101—03
20111—25
20121—01
20130—02
20142—05
20152—01
20160—02
20170—02
20180—00
20190—05
20200—00
20210—01
20220—00
20231—01
20241—05
20252—03
20260—0—

What is it indicated for?

The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical muscles and vertebrae when used in conjunction with fixed or variable height traction tables. It is indicated for use as a treatment for spinal root impingement, joint hypomobility, degenerative joint disease, discogenic pain, joint pain and compression fractures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K992733: Akron ATP9 Traction Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992733

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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