510(k) · Cleared
ClearedHeelbo Pullover Poncho and Pullover Poncho with Pocket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heelbo, Inc. · FMQ Restraint, Protective
Cleared on Nov 1, 1996 after an 84-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 1, 1996
- Review
- 84 days
- Class
- Class I
- Product code
- FMQ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK963099 Heelbo Pullover Poncho and Pullover Poncho with PocketHeelbo, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK980640 Heelbo Waist and Chest VestHeelbo, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K980640Heelbo Waist and Chest VestHeelbo, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963099 | Heelbo Pullover Poncho and Pullover Poncho with Pocket | Heelbo, Inc. | 1996 | — |
| +1 | K980640 | Heelbo Waist and Chest Vest | Heelbo, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 FMQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | — | Heelbo Pullover Poncho and Pullover Poncho with Pocket Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980640 | Heelbo Waist and Chest Vest | 1998 | 0 |
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?
- Of its descendants, K980640 (Heelbo, Inc., 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FMQ devicesFMQ Restraint, Protective: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMQ
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · FMQ
Too few FMQ 510(k)s in any year since 2007 to give a median.
Recalls per year · FMQ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FMQ
14in 2025
MAUDE reports naming product code FMQ, 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 | 16 |
| 2008 | 1 | — | 2 | 10 |
| 2009 | 1 | — | 22 | 42 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 1 | — | 0 | 31 |
| 2012 | 0 | — | 1 | 71 |
| 2013 | 0 | — | 0 | 31 |
| 2014 | 0 | — | 2 | 43 |
| 2015 | 0 | — | 0 | 33 |
| 2016 | 0 | — | 0 | 24 |
| 2017 | 0 | — | 0 | 54 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 1 | 57 |
| 2020 | 0 | — | 0 | 38 |
| 2021 | 0 | — | 1 | 33 |
| 2022 | 0 | — | 0 | 54 |
| 2023 | 0 | — | 0 | 47 |
| 2024 | 0 | — | 0 | 58 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho’s are also intended to limit the patient’s movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails.
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/K963099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963099: Heelbo Pullover Poncho and Pullover Poncho with Pocket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963099
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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