# K123746: Ames Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Ames Technology, Inc.
- Decided: May 24, 2013 after 169 days
- Product code: IKK (System, Isokinetic Testing And Evaluation)
- Device class: 2
- Regulation: 21 CFR 890.1925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905525 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951770: Biodex System 3 Model S3S-AP and Model S3D-3AP, Biodex Medical Systems, Inc. (1995) Summary page 1.
- (no number) Vibracussor: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K123746
Methodology: https://510kreport.com/methodology