510(k) · Cleared
ClearedPediatric Folding Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Columbia Medical Mfg, LLC · LBE Stroller, Adaptive
Cleared on Oct 16, 2013 as substantially equivalent to K810676 (Convaid Products, Inc., 1981) after a 219-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Oct 16, 2013
- Review
- 219 days
- Class
- Class I
- Product code
- LBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K810676 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK810676 Convaid Cruiser CP4MConvaid Products, Inc. · 1981
- This deviceK130644 Pediatric Folding WheelchairColumbia Medical Mfg, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810676 | Convaid Cruiser CP4M | Convaid Products, Inc. | 1981 | — |
| 0 (this device) | K130644 | Pediatric Folding Wheelchair | Columbia Medical Mfg, LLC | 2013 | — |
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 LBE? 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 LBE device
- #1 K223533 Little Wave Arc; Little Wave Flipscore 5.9 · 1 generation · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K810676 | Convaid Cruiser CP4MSummary page 1…Manufacturer Name: Convaid Products, Inc. Name: Cruiser CP4M K Number: K810676 Date Cleared: 03/26/1 981 4) Description of the device: This pediatric wheelch… | 1981 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LBE devicesLBE Stroller, Adaptive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LBE
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LBE
Too few LBE 510(k)s in any year since 2007 to give a median.
Recalls per year · LBE
No recall names LBE since 2007.
Adverse event reports per year · LBE
1in 2025
MAUDE reports naming product code LBE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Columbia Medical Pediatric Folding Wheelchair is a manually propelled wheelchair
designed to provide mobility aid for children and adolescents who have limited or no
ability to ambulate and require a device to aid in seated mobility in the home and
community.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130644: Pediatric Folding Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130644
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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