510(k) · Cleared

Cleared

Zegra Posture Trainer

K081540510(k) TraditionalCleared Feb 20, 2009263-day reviewClass U

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

Peter Fischer · LZW Monitor, Spine Curvature

Cleared on Feb 20, 2009 as substantially equivalent to K951244 (Dan Kline, 1995) after a 263-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Feb 20, 2009
Review: 263 days
Class: Class U
Product code: LZW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951244 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK951244 Spine Tuner Posture TrainerDan Kline · 1995
This deviceK081540 Zegra Posture TrainerPeter Fischer · 2009
Descendant · cites it directly · 0 of its ownK093553 PosturetekPerseus Althetics,Llc · 2010

Most influential descendants

Showing 1 of 1 · See all

K093553PosturetekPerseus Althetics,Llc · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951244	Spine Tuner Posture Trainer	Dan Kline	1995	—
0 (this device)	K081540	Zegra Posture Trainer	Peter Fischer	2009	—
+1	K093553	Posturetek	Perseus Althetics,Llc	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K081540, 1995–2010Source: 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 LZW? 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

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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
*	K951244	Spine Tuner Posture Trainer Summary page 1 …l: Physical Medicine Substantial equivalence: Device Classification Name - Monitor. Spine Curvature 51 0(k) Number - K951244 Device Name - SPINE TUNER POSTURE TRAINER Applicant - Dan Kline, 1816 Wes…	Dan Kline	1995	—

Also cleared against K951244: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093553	Posturetek	Perseus Althetics,Llc	2010	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?

Its one ancestor has no recall.
Of its descendants, K093553 (Perseus Althetics,Llc, 2010) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K951244.

How does its category compare?

All LZW devices

LZW Monitor, Spine Curvature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LZW

1in 2010

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZW

Too few LZW 510(k)s in any year since 2007 to give a median.

Recalls per year · LZW

No recall names LZW since 2007.

Adverse event reports per year · LZW

1in 2025

2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code LZW, 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	0	—	0
2008	0	—	0
2009	1	—	0
2010	1	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	1
2026	0	—	—

What is it indicated for?

The intended use of the ZEGRA Posture Trainer is a postural reminder for people who have the habit of slumped posture, who wish to be reminded of their posture whenever they slump beyond a predetermined limit, and who have the ability to correct their posture. The ZEGRA Posture Trainer's feedback helps to reduce slumped posture within this population.

The intended use is for Prescription Use and Over-The-Counter Use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081540 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081540: Zegra Posture Trainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081540

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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