510(k) · Cleared
ClearedRTD Arm Assistive Robotic Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rehabilitation Technologies Division · ITI Wheelchair, Powered
Cleared on Dec 17, 1999 as substantially equivalent to K954427 (Kinetic Rehabilitation Instruments, Inc., 1996) and 1 other predicate after a 66-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Dec 17, 1999
- Review
- 66 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K791931 (1979). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK791931 Prehensile HandTherapeutic Recreation Systems, Inc. · 1979
- This deviceK993443 RTD Arm Assistive Robotic DeviceRehabilitation Technologies Division · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791931 | Prehensile Hand | Therapeutic Recreation Systems, Inc. | 1979 | — |
| 0 (this device) | K993443 | RTD Arm Assistive Robotic Device | Rehabilitation Technologies Division | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954427 | Helping HandSummary page 2…tary/Trade Name: RTD Arm Classification Name: Prosthesis Predicate Devices: Device Name Company 510(k) Helping Hand Kinetic Rehabilitation Instruments K954427 Prehensile Hand Therapeutic Recreation Systems K791931 Description: The RTD Arm is a wheelchair-mountable powered electromecha… | 1996 |
| * | K791931 | Prehensile HandSummary page 2…Predicate Devices: Device Name Company 510(k) Helping Hand Kinetic Rehabilitation Instruments K954427 Prehensile Hand Therapeutic Recreation Systems K791931 Description: The RTD Arm is a wheelchair-mountable powered electromechanical arm which permits persons with severe disabilities… | 1979 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
What is it indicated for?
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…
Read the full statement (151 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993443: RTD Arm Assistive Robotic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993443
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026