# DEN120016: Deka Arm System

- Pathway: De Novo (Post-NSE)
- Applicant: Deka Integrated Solutions Corporation
- Decided: May 9, 2014 after 693 days
- Product code: PAE (Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography)
- Device class: 2
- Regulation: 21 CFR 890.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The DEKA Arm System consists of a prosthetic arm and accessories, which are used by a certified prosthetist to create a full upper extremity prosthesis indicated for individuals, age 18 years and older, who have partial or full upper limb amputations or congenital defects. The device is used to assist in activities of daily living (ADLs).

Source page: https://510kreport.com/device/DEN120016
Methodology: https://510kreport.com/methodology