510(k) · Cleared
ClearedChunc Junior Model# SM 242, Chunc Adapt Model# SM 251
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectris Technologies, Inc. · IOR Wheelchair, Mechanical
Cleared on Sep 8, 2004 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 8, 2004
- Review
- 14 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IOR? 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 IOR device
- #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IOR
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · IOR
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IOR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOR
135in 2025
MAUDE reports naming product code IOR, 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 | 5 | 38 | 1 | 36 |
| 2008 | 13 | 32 | 3 | 62 |
| 2009 | 4 | 43 | 2 | 54 |
| 2010 | 12 | 81 | 0 | 69 |
| 2011 | 6 | 58 | 6 | 232 |
| 2012 | 11 | 176 | 3 | 1,238 |
| 2013 | 7 | 233 | 3 | 4,674 |
| 2014 | 7 | 211 | 3 | 5,082 |
| 2015 | 3 | 104 | 0 | 4,472 |
| 2016 | 10 | 135 | 1 | 1,860 |
| 2017 | 7 | 209 | 0 | 49 |
| 2018 | 3 | 203 | 0 | 58 |
| 2019 | 6 | 160 | 0 | 53 |
| 2020 | 2 | — | 0 | 43 |
| 2021 | 2 | — | 1 | 59 |
| 2022 | 4 | 150 | 0 | 37 |
| 2023 | 9 | 61 | 0 | 165 |
| 2024 | 4 | 65 | 0 | 138 |
| 2025 | 7 | 91 | 0 | 135 |
| 2026 | 17 | 103 | 0 | — |
What is it indicated for?
Chunc pediatric attendant controlled wheelchair is intended for clients with moderate to specialist needs and has been designed with the occupants and attendants need first and foremost. Chunc manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions such as: Arthritis Tetraplegic Multiple Sclerosis Amputee Quadriplegic Polio Paraplegic Spina Bifida Cerebral Palsy Muscular…
Read the full statement (234 words)
Chunc pediatric attendant controlled wheelchair is intended for clients with moderate to specialist needs and has been designed with the occupants and attendants need first and foremost.
Chunc manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions such as:
Arthritis Tetraplegic Multiple Sclerosis
Amputee Quadriplegic Polio
Paraplegic Spina Bifida Cerebral Palsy
Muscular Dystrophy and Any other immobilizing or debilitating condition
The modular design of the wheelchair chassis, frame and seating allows for flexibility and ease of modification to suit postural, functional and social needs. This coupled with material choice and the frequent use of like parts across the wheelchair have enabled us to keep costs at a minimum.
Attendant functions have been designed to be easily identifiable from engineered functions using unified adjustments with color coding which are also simple to use and maintain. By moving away from the cumbersome welded steel structures of conventional wheelchairs we have been able to utilize a selection of materials and manufacturing techniques to ensure the wheelchair is lightweight and therefore comfortable to use. Chunc is currently manufactured and marketed in the UK and has been approved by the National Health Service (NHS) and has the relevant CE marking. Chunc also provides the ability for Bus Transportation and motor vehicle transportation with the use of wheelchair tiedown and occupant restraints systems (WTORS) that meet the requirements of SAE 12249
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042304 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042304: Chunc Junior Model# SM 242, Chunc Adapt Model# SM 251.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042304
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026