# K951770: Biodex System 3 Model S3S-AP and Model S3D-3AP

- Pathway: 510(k) (Traditional)
- Applicant: Biodex Medical Systems, Inc.
- Decided: Nov 16, 1995 after 213 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: 1 generation back to K905525 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915648: Biodex System 2 Autoprogram, Biodex Corp. (1992)
- K913021: Biodex,Model B-2000, Biodex Corp. (1991) Summary page 1.
- K905525: CYBEX 6000, Cybex (1991) Summary page 1.

## Most influential descendants
- K123746: Ames Therapy Device (2013), 0 descendants of its own

## Indications for use
This device is designed for physical therapy to exercise, measure, evaluate and increase the strength of muscles and increase the Range of Motion (ROM) of joints.

Source page: https://510kreport.com/device/K951770
Methodology: https://510kreport.com/methodology