# K993963: Sigma Manual Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Distribution & Supply, Inc.
- Decided: Jan 13, 2000 after 52 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- 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 K915262 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945175: Mechanical Wheelchair 890.3850, Lumex, Inc. (1995). 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”.
- K935398: Tracer Series Manual Wheelchairs, Invacare Corp. (1994) Summary page 1.
- K915262: Bantex Brand Wheelchairs, Bantex Corp. (1992) Summary page 1.

## Indications for use
For transportation of disabled persons.

Source page: https://510kreport.com/device/K993963
Methodology: https://510kreport.com/methodology