510(k) Report

510(k) · Cleared

Cleared

Orthotic Leg Gait Corrector Device

K800716510(k) TraditionalCleared May 2, 198032-day reviewClass I21 CFR 890.3410

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

Ipos Luneburg · ITO Twister, Brace Setting

Cleared on May 2, 1980 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 2, 1980
Review
32 days
Class
Class I
Product code
ITO
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K800716Source: FDA 510(k) database · How lineage is built

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

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All ITO devices

ITO Twister, Brace Setting: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITO

FDA has decided no ITO device since 2007.

Median 510(k) review, days · ITO

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

Recalls per year · ITO

No recall names ITO since 2007.

Adverse event reports per year · ITO

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code ITO, 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
20090—00
20100—00
20110—00
20120—00
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Ipos Luneburg

8 FDA decisions under this applicant name. See the company

  • K834143Nylon Compression Stump SheathIpos Luneburg · 1984
  • K833868Ipos G.L.P. SystemIpos Luneburg · 1983
  • K831690Ipos Anti-Adductus ShoeIpos Luneburg · 1983
  • K802976CarbonacrylIpos Luneburg · 1980
  • K802977Ipocarbon Stretch StockinetteIpos Luneburg · 1980

https://510kreport.com/device/K800716 · printed Nov 6, 2026

Cite this page

510(k) Report. “K800716: Orthotic Leg Gait Corrector Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800716

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026