510(k) Report

510(k) · Cleared

Cleared

Posturetek

K093553510(k) TraditionalCleared Aug 13, 2010269-day reviewClass U

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

Perseus Althetics,Llc · LZW Monitor, Spine Curvature

Cleared on Aug 13, 2010 as substantially equivalent to K081540 (Peter Fischer, 2009) and 1 other predicate after a 269-day review. Its family tree reaches back 2 generations to 1995.

Decided
Aug 13, 2010
Review
269 days
Class
Class U
Product code
LZW
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K951244 (1995). No later device cites it as a predicate yet.

  1. Root · 2 generations backK951244 Spine Tuner Posture TrainerDan Kline · 1995
  2. 1 generation backK081540 Zegra Posture TrainerPeter Fischer · 2009
  3. This deviceK093553 PosturetekPerseus Althetics,Llc · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K951244Spine Tuner Posture TrainerDan Kline1995—
−1K081540Zegra Posture TrainerPeter Fischer2009—
0 (this device)K093553PosturetekPerseus Althetics,Llc2010—
FIG. 1 — Lineage of K093553, 1995–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K081540Zegra Posture TrainerPeter Fischer2009—
*K951244Spine Tuner Posture TrainerDan Kline1995—

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 15 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All LZW devices

LZW Monitor, Spine Curvature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · LZW

1in 2010

2009: 12010: 1
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

2021: 12025: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—01
20260—0—

What is it indicated for?

The Posture~Tek Shirt provides training to help the wearer use his own muscles to maintain the desired posture, thereby correcting poor posture and improving appearance

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K093553: Posturetek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093553

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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