# K112121: Ergoselect/GE

- Pathway: 510(k) (Traditional)
- Applicant: Ergoline GmbH
- Decided: Oct 31, 2012 after 464 days
- Product code: ISD (Exerciser, Measuring)
- Device class: 2
- Regulation: 21 CFR 890.5360
- 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 K851097 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053078: Ergoselect 100 K/P, Ergoselect 200 K/P, Ergoline GmbH (2006) Summary page 1.

## Indications for use
Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.

Source page: https://510kreport.com/device/K112121
Methodology: https://510kreport.com/methodology