510(k) · Cleared

Cleared

E-Teng Model Eor 1

K122562510(k) TraditionalCleared Aug 9, 2013352-day reviewClass II21 CFR 890.3900

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

E-Teng Technology, Inc. · IPL Wheelchair, Standup

Cleared on Aug 9, 2013 as substantially equivalent to K030893 (Levo AG, 2003) after a 352-day review. Its family tree reaches back 2 generations to 1997.

Decided: Aug 9, 2013
Review: 352 days
Class: Class II
Product code: IPL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K963817 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK963817 Levo Mobil LCMLevo USA · 1997
1 generation backK030893 Levo CombiLevo AG · 2003
This deviceK122562 E-Teng Model Eor 1E-Teng Technology, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K963817	Levo Mobil LCM	Levo USA	1997	—
−1	K030893	Levo Combi	Levo AG	2003	—
0 (this device)	K122562	E-Teng Model Eor 1	E-Teng Technology, Inc.	2013	—

FIG. 1 — Lineage of K122562, 1997–2013Source: 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 IPL? 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 IPL device

#1 K203761 ParaMotionscore 3.3 · 3 generations · no Class I recall
#2 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
*	K030893	Levo Combi Summary page 1 …Device Regulation number: 890.3900 Product Code: IPL Classification: Class 11 Predicate devices Trade name: LEVO Combi Manufacture: LEVO AG 5 10(k) number: K030893 Regulation number: 890.3900 Product Code: IPL Classification: Class 11 Intend use of device The device is a product whic…	Levo AG	2003	—

Also cleared against K030893: 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 16 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K030893.

How does its category compare?

All IPL devices

IPL Wheelchair, Standup: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · IPL

1in 2025

2007high 3 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPL

105in 2019

2007high 105 (2019) · low 63 (2007)2026

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

Recalls per year · IPL

No recall names IPL since 2007.

Adverse event reports per year · IPL

5in 2025

2007high 9 (2023) · low 0 (2007)2025

MAUDE reports naming product code IPL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	3	63	0
2008	1	—	1
2009	1	—	0
2010	2	—	1
2011	0	—	0
2012	0	—	0
2013	1	—	3
2014	0	—	1
2015	1	—	3
2016	0	—	0
2017	0	—	0
2018	2	—	1
2019	3	105	1
2020	2	—	0
2021	0	—	4
2022	2	—	3
2023	0	—	9
2024	0	—	6
2025	1	—	5
2026	0	—	—

What is it indicated for?

The device is a product which changes people's position from standing to sitting or

sitting to standing and any position in between. The product provides indoor and

outdoor mobility on surfaces like tar, grass and gravel. However, it should not be

driven in the standing position on uneven ground.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122562 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122562: E-Teng Model Eor 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122562

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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