510(k) Report

510(k) · Cleared

Cleared

Massager Theraputic, Electric

K954203510(k) TraditionalCleared Dec 11, 199595-day reviewClass I21 CFR 890.5975

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

Cisco Sales Corp. · IRO Vibrator, Therapeutic

Cleared on Dec 11, 1995 after a 95-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 11, 1995
Review
95 days
Class
Class I
Product code
IRO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K954203Source: 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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  • 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 IRO devices

IRO Vibrator, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IRO

FDA has decided no IRO device since 2007.

Median 510(k) review, days · IRO

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

Recalls per year · IRO

No recall names IRO since 2007.

Adverse event reports per year · IRO

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2025

MAUDE reports naming product code IRO, 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—02
20100—00
20110—00
20120—00
20130—00
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—

Recent decisions in IRO

The IRO category page

  • K955160Comfort, Muscle, Cordless Massager, Battery Powered Operated MassagerEverapex Design & Marketing Corp. · 1996
  • K955250QI Gong MassagerEast Health Development Group, Inc. · 1996
  • K952916Shiatsu Master Massager CushionKinsei Shiatsu, Inc. · 1995
  • K951414Champion Physioacousticc Recliner-Transporter ChairChampion Mfg. Corp. · 1995
  • K950441Conair Family Fitness Body EnergyConair Corp. · 1995

https://510kreport.com/device/K954203 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954203: Massager Theraputic, Electric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954203

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