510(k) · Cleared

Cleared

Tipower TR Rimpower and Tipower Tra Rimpower

K020639510(k) TraditionalCleared Jun 20, 2002113-day reviewClass II21 CFR 890.3860

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

Tisport · ITI Wheelchair, Powered

Cleared on Jun 20, 2002 as substantially equivalent to K934232 (Fortress Lite-Style Wheelchairs, Inc., 1994) after a 113-day review. Its family tree reaches back 1 generation to 1994.

Decided: Jun 20, 2002
Review: 113 days
Class: Class II
Product code: ITI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K934232 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK934232 Commuter (Manual/Power Wheelclhair)Fortress Lite-Style Wheelchairs, Inc. · 1994
This deviceK020639 Tipower TR Rimpower and Tipower Tra RimpowerTisport · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934232	Commuter (Manual/Power Wheelclhair)	Fortress Lite-Style Wheelchairs, Inc.	1994	—
0 (this device)	K020639	Tipower TR Rimpower and Tipower Tra Rimpower	Tisport	2002	—

FIG. 1 — Lineage of K020639, 1994–2002Source: 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 ITI? 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 ITI device

#1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 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
*	K934232	Commuter (Manual/Power Wheelclhair) Summary page 1 …ss II Panel: Physical Medicine Device Prosthetic Devices Subpart D Product Code: 890.3860 (Powered Wheelchair) Legally Marketed Device Claiming Equivalence To: Commuter (K934232) Description of Device: The TiPower TR Rim Power and TiPower TRA RimPower are rigid power/manual titanium wheelchairs. Intended…	Fortress Lite-Style Wheelchairs, Inc.	1994	—

Also cleared against K934232: 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?

Its one ancestor has no recall.
1 other device also cites its predicate K934232.

How does its category compare?

All ITI devices

ITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITI

29in 2025

2007high 38 (2024) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITI

90in 2025

2007high 278 (2020) · low 42 (2007)2026

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

Recalls per year · ITI

13so far in 2026, the most since 2007

2007high 13 (2026) · low 0 (2011)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · ITI

647in 2025

2007high 8,741 (2013) · low 123 (2007)2025

MAUDE reports naming product code ITI, 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	18	42	3	123
2008	9	49	3	133
2009	7	63	1	183
2010	6	46	2	157
2011	4	101	0	525
2012	6	155	1	2,919
2013	5	177	0	8,741
2014	5	213	0	7,282
2015	10	174	0	4,685
2016	6	173	1	1,575
2017	4	159	2	301
2018	4	117	0	273
2019	3	244	0	264
2020	6	278	0	205
2021	13	209	3	166
2022	16	96	0	135
2023	8	128	0	223
2024	38	125	1	146
2025	29	90	3 (2)	647
2026	36	108	13	—

What is it indicated for?

The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the powerlmanual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair.

The specific medical conditions for which the device is indicated are listed as, but not limited to:

Spinal chord injury

Stoke/CVA

Post Polio Syndrome

Spina Bifada

Amputee

Multiple Sclerosis

Arthrogriposis

Muscular Dystrophy

Lower and upper extremity paralysis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020639 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020639: Tipower TR Rimpower and Tipower Tra Rimpower.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020639

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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