510(k) Report

510(k) · Cleared

Cleared

Quantum Intersegmental Traction Table 400, 401, 400H,401H

K002390510(k) TraditionalCleared Nov 2, 200090-day reviewClass II21 CFR 890.5880

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

Lsi Intl., Inc. · JFB Table, Physical Therapy, Multi Function

Cleared on Nov 2, 2000 as substantially equivalent to K993461 (Icon Intl., LLC, 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000. 13 later devices descend from it.

Decided
Nov 2, 2000
Review
90 days
Class
Class II
Product code
JFB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K993461 (2000). 13 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2003: 1 descendant cleared2004: 1 descendant cleared2014: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2006: 1 descendant cleared2010: 1 descendant cleared2021: 2 descendants cleared2022: 1 descendant cleared2024: 1 descendant clearedK993461 · Quest Intersegmental Roller Traction Table · Icon Intl., LLC · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K993461 · Quest Intersegmental Roller Traction Table · Icon Intl., LLC · 20000+5
  1. Root · 1 generation backK993461 Quest Intersegmental Roller Traction TableIcon Intl., LLC · 2000
  2. This deviceK002390 Quantum Intersegmental Traction Table 400, 401, 400H,401HLsi Intl., Inc. · 2000
  3. Descendant · cites it directly · 11 of its ownK032449 Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd. · 2003
  4. Descendant · 2 generations on · 10 of its ownK040031 Ceragem-C Thermal Acupressure MassagerCeragem Co., Ltd. · 2004
  5. Descendant · 3 generations on · 4 of its ownK140592 Ceragem Automatic Thermal MassagerCeragem International, Inc. · 2014
  6. Descendant · 3 generations on · 3 of its ownK062476 Ceragem RH1 Automatic Thermal MassagerCeragem International, Inc. · 2006
  7. Descendant · 4 generations on · 2 of its ownK202937 Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd. · 2021

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12006: 12007: 12008: 12010: 12012: 22014: 12021: 22022: 12024: 1
2003high 2 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 13 · See all
  • K032449Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd. · 2003 · cites it directly11descendants
  • K040031Ceragem-C Thermal Acupressure MassagerCeragem Co., Ltd. · 2004 · 2 generations on10descendants
  • K140592Ceragem Automatic Thermal MassagerCeragem International, Inc. · 2014 · 3 generations on4descendants
  • K062476Ceragem RH1 Automatic Thermal MassagerCeragem International, Inc. · 2006 · 3 generations on3descendants
  • K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd. · 2021 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K993461Quest Intersegmental Roller Traction TableIcon Intl., LLC2000—
0 (this device)K002390Quantum Intersegmental Traction Table 400, 401, 400H,401HLsi Intl., Inc.2000—
+1K032449Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd.2003—
+2K040031Ceragem-C Thermal Acupressure MassagerCeragem Co., Ltd.2004—
+3K140592Ceragem Automatic Thermal MassagerCeragem International, Inc.2014—
+3K062476Ceragem RH1 Automatic Thermal MassagerCeragem International, Inc.2006—
+4K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200610
200710
200810
201010
201220
201410
202120
202210
202410
FIG. 1 — Lineage of K002390, 2000–2024Source: 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 JFB? 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 JFB device

  1. #1 K240168 N7-Sscore 9.8 · 7 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? (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
*K993461Quest Intersegmental Roller Traction Table
Summary page 1
…Therapy Table Predicate Device Equivaleiite: Substantial equivalence xsclmmcd to the Quest Intersegmental Roller Traction Table, cleared for commercial distribution per K993461. Indications: The Quamuft:n :Efiitersegmental Roller Traction Table is designed to release muscle tension and deliver:a §oothing…
Icon Intl., LLC2000—

Also cleared against K993461: 1 other device →

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032449Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd.200311
K111588Legacy-500Mt Tables, LLC20120

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.
  • Of its descendants, K032449 (Migun Medical Instrument Co., Ltd., 2003) has gone furthest, with 11 descendants of its own.
  • 1 other device also cites its predicate K993461.

How does its category compare?

All JFB devices

JFB Table, Physical Therapy, Multi Function: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JFB

3in 2025

2007: 12008: 12010: 22011: 22012: 22014: 12016: 12021: 22022: 12024: 22025: 3
2007high 3 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JFB

162in 2025

2025: 162 days median
2007high 162 (2025)2026

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

Recalls per year · JFB

No recall names JFB since 2007.

Adverse event reports per year · JFB

1in 2024

2007: 32008: 32009: 32010: 12011: 12012: 22013: 22020: 12022: 22024: 1
2007high 3 (2007) · low 0 (2014)2025

MAUDE reports naming product code JFB, 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
20071—03
20081—03
20090—03
20102—01
20112—01
20122—02
20130—02
20141—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—01
20212—00
20221—02
20230—00
20242—01
2025316200
20260—0—

What is it indicated for?

The Quantum Intersegmental Roller Traction Table uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient.

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. “K002390: Quantum Intersegmental Traction Table 400, 401, 400H,401H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002390

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026