510(k) · Cleared

Cleared

Profthand Mechanical Wheelchair

K123076510(k) AbbreviatedCleared Aug 9, 2013312-day reviewClass I21 CFR 890.3850

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

Harmony Hill International · IOR Wheelchair, Mechanical

Cleared on Aug 9, 2013 as substantially equivalent to K083231 (Panthera Production AB, 2009) after a 312-day review. Its family tree reaches back 4 generations to 1992.

Decided: Aug 9, 2013
Review: 312 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K922535 (1992). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK922535 The TerminatorTop End Wheelchair Sports, Inc. · 1992
3 generations backK990157 Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999
2 generations backK012167 Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001
1 generation backK083231 Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTPanthera Production AB · 2009
This deviceK123076 Profthand Mechanical WheelchairHarmony Hill International · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K922535	The Terminator	Top End Wheelchair Sports, Inc.	1992	—
−3	K990157	Model Top End Terminator SS Manual Wheelchair	Invacare Corp.	1999	—
−2	K012167	Model Top End Terminator Titanium Manual Wheelchair	Invacare Corp.	2001	—
−1	K083231	Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT	Panthera Production AB	2009	—
0 (this device)	K123076	Profthand Mechanical Wheelchair	Harmony Hill International	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K123076, 1992–2013Source: 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? (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	Applicant	Decided	Recalls
*	K083231	Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT Summary page 2 …lity to persons that have the capability of operating a mechanical wheelchair. 7. Predicate Devices Panthera Mechanical wheelchairs / Model S2 (K083231) 8. Safety and Effectiveness By definition, the HM-1O0 device is substantially equivalent to a predicate device…	Panthera Production AB	2009	—

Also cleared against K083231: 1 other device →

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?

The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
None of the 5 ancestors has a recall.
1 other device also cites its predicate K083231.

How does its category compare?

All IOR devices

IOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?

Profhand pedal wheelchair is manually operated multifunctional wheelchairs designed

for indoor/outdoor use and intended to provide mobility to persons that have the

capability of operating a mechanical wheelchair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123076 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123076: Profthand Mechanical Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123076

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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