510(k) · Cleared

Recalled · Class II · 2013

Rehab TNT, Rehab Ram, Rehab Mac, Rehab Kidster, Bariatric Rehab TNT and Rehab Ram

K111636510(k) TraditionalCleared Apr 3, 2012295-day reviewClass I21 CFR 890.3850Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gunnell, Inc. · IOR Wheelchair, Mechanical

Cleared on Apr 3, 2012 as substantially equivalent to K971389 (Pdg Product Design Group, Inc., 1997) and 4 other predicates after a 295-day review. Its family tree reaches back 3 generations to 1994. It has been recalled once.

Decided: Apr 3, 2012
Review: 295 days
Class: Class I
Product code: IOR
Recalls: 1
Predicates: 5

Its longest line of descent runs back 3 generations to K941989 (1994). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK941989 Action at Manual WheelchairNvacare Corp. · 1994
2 generations backK984447 Model Action at II Manual WheelchairInvacare Corp. · 1999 · Recalled
1 generation backK063736 Fuze Mechanical Wheelchair, Models T20 and T50Pdg Product Design Group, Inc. · 2007 · Recalled
This deviceK111636 Rehab TNT, Rehab Ram, Rehab Mac, Rehab Kidster, Bariatric Rehab TNT…Gunnell, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K941989	Action at Manual Wheelchair	Nvacare Corp.	1994	—
−2	K984447	Model Action at II Manual Wheelchair	Invacare Corp.	1999	1
−1	K063736	Fuze Mechanical Wheelchair, Models T20 and T50	Pdg Product Design Group, Inc.	2007	1
0 (this device)	K111636	Rehab TNT, Rehab Ram, Rehab Mac, Rehab Kidster, Bariatric Rehab TNT and Rehab…	Gunnell, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1997	1	0
1999	1	0
2008	1	0

FIG. 1 — Lineage of K111636, 1994–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K971389	Eclipse 400 Manually Operated Wheelcair Summary page 1 …ame: Manual Wheelchair Classification Name: Wheelchair, Mechanical Regulatory Class: Class \| Product Code: IOR Identification of Predicate Devices: PDG Eclipse 400 (#K971389) 5/9/1997 PDG Stellar (#K990557) 3/22/1999 PDG Eclipse 600 (#K961743) 5/29/1996 Freedom CGX (#K080270) 4/16/2008 PDG Fuze T50J…	Pdg Product Design Group, Inc.	1997	—
*	K990557	The Stellar Tilt, Manually Operated Wheelchair Summary page 1 …ation Name: Wheelchair, Mechanical Regulatory Class: Class \| Product Code: IOR Identification of Predicate Devices: PDG Eclipse 400 (#K971389) 5/9/1997 PDG Stellar (#K990557) 3/22/1999 PDG Eclipse 600 (#K961743) 5/29/1996 Freedom CGX (#K080270) 4/16/2008 PDG Fuze T50Jr. (#K063736) 1/17/2007 INTENDE…	Pdg Product Design Group, Inc.	1999	—
*	K961743	Eclipse 600 Manually Operated Wheelchair Summary page 1 …egulatory Class: Class \| Product Code: IOR Identification of Predicate Devices: PDG Eclipse 400 (#K971389) 5/9/1997 PDG Stellar (#K990557) 3/22/1999 PDG Eclipse 600 (#K961743) 5/29/1996 Freedom CGX (#K080270) 4/16/2008 PDG Fuze T50Jr. (#K063736) 1/17/2007 INTENDED USE The purpose of The Gunnell Reh…	Pdg Product Design Group, Inc.	1996	—
*	K080270	Manual Rigid Mobility Wheelchair Summary page 1 …Code: IOR Identification of Predicate Devices: PDG Eclipse 400 (#K971389) 5/9/1997 PDG Stellar (#K990557) 3/22/1999 PDG Eclipse 600 (#K961743) 5/29/1996 Freedom CGX (#K080270) 4/16/2008 PDG Fuze T50Jr. (#K063736) 1/17/2007 INTENDED USE The purpose of The Gunnell Rehab Series Wheelchairs is to provid…	Freedom Designs, Inc.	2008	—
*	K063736	Fuze Mechanical Wheelchair, Models T20 and T50 Summary page 1 …Devices: PDG Eclipse 400 (#K971389) 5/9/1997 PDG Stellar (#K990557) 3/22/1999 PDG Eclipse 600 (#K961743) 5/29/1996 Freedom CGX (#K080270) 4/16/2008 PDG Fuze T50Jr. (#K063736) 1/17/2007 INTENDED USE The purpose of The Gunnell Rehab Series Wheelchairs is to provide mobility to individuals limited to a…	Pdg Product Design Group, Inc.	2007	1

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 18, 2013	Class II	Z-0809-2013	Labeling False and Misleading	The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW).

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
2 of the 8 ancestors have a recall of any class.

How does its category compare?

All IOR devices

IOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · IOR

17so far in 2026, the most since 2007

2007high 17 (2026) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IOR

91in 2025

2007high 233 (2013) · low 32 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IOR

1in 2021

2007high 6 (2011) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IOR

135in 2025

2007high 5,082 (2014) · low 36 (2007)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?

The intended use of all of the GRSW’s is to provide mobility to individuals restricted to a sitting position.

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/K111636 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111636: Rehab TNT, Rehab Ram, Rehab Mac, Rehab Kidster, Bariatric Rehab TNT and Rehab Ram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111636

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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