510(k) · Cleared
ClearedSigma Manual Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Distribution & Supply, Inc. · IOR Wheelchair, Mechanical
Cleared on Jan 13, 2000 as substantially equivalent to K945175 (Lumex, Inc., 1995) and 2 other predicates after a 52-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jan 13, 2000
- Review
- 52 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K915262 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915262 Bantex Brand WheelchairsBantex Corp. · 1992
- This deviceK993963 Sigma Manual WheelchairSigma Distribution & Supply, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915262 | Bantex Brand Wheelchairs | Bantex Corp. | 1992 | — |
| 0 (this device) | K993963 | Sigma Manual Wheelchair | Sigma Distribution & Supply, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K945175 | Mechanical Wheelchair 890.3850 Our OCR of the scanned summary read K943175, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Mechanical Wheelchair”. | 1995 |
| * | K935398 | Tracer Series Manual WheelchairsSummary page 1…above. Please sec the enclosed catalog pages of FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY comparcd with the dimensions of Invacare Tracer Series wheelchairs (510(k) #K935398) for a comparison of design features, which we belicve to be equivalent to our submitted wheelchair. Some items for comparison ar… | 1994 |
| * | K915262 | Bantex Brand WheelchairsSummary page 1…tial equivalence, together with their 510(k) numbers are as follows: Mechanical Wheelchair 980.3850, K943175 Tracer Series Wheelchairs, K35398 Bantex Brand Wheelchairs, K915262 (4) The device consists of a chromed steel frame with cross bars, slung fabric seat and back, fixed or removable armrests, fixed… | 1992 |
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 3 ancestors has a 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?
For transportation of disabled persons.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993963 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993963: Sigma Manual Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993963
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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