510(k) Report

510(k) · Cleared

Cleared

Ames Therapy Device

K123746510(k) TraditionalCleared May 24, 2013169-day reviewClass II21 CFR 890.1925

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

Ames Technology, Inc. · IKK System, Isokinetic Testing And Evaluation

Cleared on May 24, 2013 as substantially equivalent to K951770 (Biodex Medical Systems, Inc., 1995) after a 169-day review. Its family tree reaches back 2 generations to 1991.

Decided
May 24, 2013
Review
169 days
Class
Class II
Product code
IKK
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K905525 (1991). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 1 other ancestor1991: 1 other ancestorK905525 · CYBEX 6000 · Cybex · 1991K951770 · Biodex System 3 Model S3S-AP and Model S3D-3AP · Biodex Medical Systems, Inc. · 1995199019952000200520102015
Other ancestors, by generation 2 generations back: 2 other ancestors K951770 · Biodex System 3 Model S3S-AP and Model S3D-3AP · Biodex Medical Systems, Inc. · 1995K905525 · CYBEX 6000 · Cybex · 19910
  1. Root · 2 generations backK905525 CYBEX 6000Cybex · 1991
  2. 1 generation backK951770 Biodex System 3 Model S3S-AP and Model S3D-3APBiodex Medical Systems, Inc. · 1995
  3. This deviceK123746 Ames Therapy DeviceAmes Technology, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K905525CYBEX 6000Cybex1991—
−1K951770Biodex System 3 Model S3S-AP and Model S3D-3APBiodex Medical Systems, Inc.1995—
0 (this device)K123746Ames Therapy DeviceAmes Technology, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
FIG. 1 — Lineage of K123746, 1991–2013Source: 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 IKK? 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? (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
*K951770Biodex System 3 Model S3S-AP and Model S3D-3AP
Summary page 1
…rently marketed physical therapy devices: 510(k) Number Product Code, Trade Name Manufacturer Class K95 1770 IKK System 4 Biodex Medical Systems, Inc. (now 510(k)-exempt)* Class 11 N…
Biodex Medical Systems, Inc.1995—
*—Vibracussor
Named without a submission number
—

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?

  • The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 17.5 years on median.
  • None of the 4 ancestors has a recall.

How does its category compare?

All IKK devices

IKK System, Isokinetic Testing And Evaluation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · IKK

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IKK

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

Recalls per year · IKK

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · IKK

2in 2024

2009: 22011: 12012: 12013: 32014: 22016: 72017: 22019: 22020: 12021: 12022: 32023: 42024: 2
2007high 7 (2016) · low 0 (2007)2025

MAUDE reports naming product code IKK, 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—00
20080—00
20090—02
20100—00
20110—01
20120—11
20131—13
20140—02
20150—00
20160—07
20170—02
20180—00
20190—02
20200—01
20210—01
20220—03
20230—04
20240—02
20250—00
20260—0—

What is it indicated for?

The AMES Therapy Device is a rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion. It also uses muscle vibration for muscle relaxation.

Indications for use as stated in the FDA summary.

Recent decisions in IKK

The IKK category page

  • K952090Humac SystemComputer Sports Medicine, Inc. · 1995
  • K951770Biodex System 3 Model S3S-AP and Model S3D-3APBiodex Medical Systems, Inc. · 1995
  • K951916CC Rider, Model ME180Mettler Electronics Corp. · 1995
  • K950095CYBEX 770Cybex · 1995
  • K942229Motivator FTR 2000Hogan & Hartson · 1995

https://510kreport.com/device/K123746 · printed Nov 3, 2026

Cite this page

510(k) Report. “K123746: Ames Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123746

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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