# K993443: RTD Arm Assistive Robotic Device

- Pathway: 510(k) (Traditional)
- Applicant: Rehabilitation Technologies Division
- Decided: Dec 17, 1999 after 66 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- 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 K791931 (1979). 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)
- K954427: Helping Hand, Kinetic Rehabilitation Instruments, Inc. (1996) Summary page 2.
- K791931: Prehensile Hand, Therapeutic Recreation Systems, Inc. (1979) Summary page 2.

## Indications for use
The RTD Arm permits persons with severe disabilities to manipulate objects in their personal environment and thus to establish a greater measure of functional independence. The client population for this device includes individuals with • very limited or complete absence of bilateral upper extremity function, • lower extremity impairment requiring the use of a power wheelchair, and • intact cognitive and visual perceptual ability. The medical diagnoses of the target user populations include high-level quadriplegia, neuromuscular disabilities, cerebral palsy, and other congenital disabilities such as spina bifida, or arthrogryposis. In addition, individuals with other types of disabilities resulting in permanent or temporary impairment to upper extremity function may also benefit from use of the RTD Arm as an aid in performing manipulation of objects. These disabilities include paraplegia, stroke, severe head injury, multiple broken bones, and severe rheumatoid arthritis, among others. The RTD Arm may be purchased as an over-the-counter device.

Source page: https://510kreport.com/device/K993443
Methodology: https://510kreport.com/methodology