# K253256: myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

- Pathway: 510(k) (Traditional)
- Applicant: Otto Bock Healthcare Products GmbH
- Decided: Apr 22, 2026 after 205 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K032833 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191179: Myo Plus, Otto Bock Healthcare Products GmbH (2019) Summary page 5.
- K240884: Glide (91000-GL-X), Infinite Biomedical Technologies, LLC (2024) Summary page 6.

## Indications for use
Myosmart is to be used exclusively for exoprosthetic fittings of the upper limbs.

Source page: https://510kreport.com/device/K253256
Methodology: https://510kreport.com/methodology