510(k) Report

510(k) · Cleared

Cleared

Umbrella Walker

K833195510(k) TraditionalCleared Oct 27, 198338-day reviewClass I21 CFR 890.3825

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

Convaid Products, Inc. · ITJ Walker, Mechanical

Cleared on Oct 27, 1983 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 27, 1983
Review
38 days
Class
Class I
Product code
ITJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K833195Source: 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.

Planning a device in ITJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 ITJ devices

ITJ Walker, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITJ

FDA has decided no ITJ device since 2007.

Median 510(k) review, days · ITJ

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

Recalls per year · ITJ

3in 2024

2007: 12009: 22011: 12012: 12014: 32016: 12018: 12019: 12022: 12023: 12024: 32026 (partial year): 2
2007high 3 (2014) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ITJ

134in 2025

2007: 572008: 1322009: 982010: 752011: 1612012: 1,0312013: 2,3092014: 2,7822015: 1,1222016: 4992017: 1312018: 1262019: 1152020: 1172021: 812022: 1142023: 1402024: 842025: 134
2007high 2,782 (2014) · low 57 (2007)2025

MAUDE reports naming product code ITJ, 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—157
20080—0132
20090—298
20100—075
20110—1161
20120—11,031
20130—02,309
20140—32,782
20150—01,122
20160—1499
20170—0131
20180—1126
20190—1115
20200—0117
20210—081
20220—1114
20230—1140
20240—384
20250—0134
20260—2—

More from Convaid Products, Inc.

8 FDA decisions under this applicant name. See the company

  • K140416Trekker, Trekker TransitConvaid Products, Inc. · 2014
  • K120501Champ Champ TransitConvaid Products, Inc. · 2012
  • K032402Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T,Convaid Products, Inc. · 2003
  • K840250CarrierConvaid Products, Inc. · 1984
  • K822992People MoverConvaid Products, Inc. · 1982

Recent decisions in ITJ

The ITJ category page

  • K833869Child's WalkerKaye Products, Inc. · 1983
  • K830784Walk N RollMeta-Morris · 1983
  • K830848Resi-WalkerLic-Orthion · 1983
  • K823105Resi-WalkerOrthion Corp. · 1982
  • K821404Light Weight Aluminum WalkerManuco Manufacturing Co., Inc. · 1982

https://510kreport.com/device/K833195 · printed Nov 4, 2026

Cite this page

510(k) Report. “K833195: Umbrella Walker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833195

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