510(k) Report

510(k) · Cleared

Cleared

ECU 1218

K840808510(k) TraditionalCleared Mar 19, 198424-day reviewClass II21 CFR 890.3725

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

Rehab Technology, Inc. · IQA System, Environmental Control, Powered

Cleared on Mar 19, 1984 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 19, 1984
Review
24 days
Class
Class II
Product code
IQA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K840808Source: 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 IQA? 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?

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 IQA devices

IQA System, Environmental Control, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IQA

FDA has decided no IQA device since 2007.

Median 510(k) review, days · IQA

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

Recalls per year · IQA

2in 2025

2011: 22018: 12021: 12023: 32024: 12025: 2
2007high 3 (2023) · low 0 (2007)2026

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

Adverse event reports per year · IQA

2in 2025

2008: 12010: 32014: 32015: 22016: 12017: 12018: 12020: 12022: 22023: 182024: 22025: 2
2007high 18 (2023) · low 0 (2007)2025

MAUDE reports naming product code IQA, 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—01
20090—00
20100—03
20110—20
20120—00
20130—00
20140—03
20150—02
20160—01
20170—01
20180—11
20190—00
20200—01
20210—10
20220—02
20230—318
20240—12
20250—22
20260—0—

More from Rehab Technology, Inc.

4 FDA decisions under this applicant name. See the company

  • K921084The ExcelsiorRehab Technology, Inc. · 1992
  • K850313Television Control Option 1219Rehab Technology, Inc. · 1985
  • K850314Television Control Option 1220Rehab Technology, Inc. · 1985

Recent decisions in IQA

The IQA category page

  • K961306Deltatalker with InfraredPrentke Romich Co. · 1996
  • K953905ImperiumTeledyne Brown Engineering · 1995
  • K953937Liaison Computer Access & Environmental Control SystemApt Technology, Inc. · 1995
  • K943244DEUCEApt Technology, Inc. · 1995
  • K944585Scanning DirectorPrentke Romich Co. · 1995

https://510kreport.com/device/K840808 · printed Nov 6, 2026

Cite this page

510(k) Report. “K840808: ECU 1218.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K840808

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