Cleared Traditional

K954203 - MASSAGER THERAPUTIC, ELECTRIC

K954203 is an FDA 510(k) clearance for MASSAGER THERAPUTIC, manufactured by Cisco Sales Corp.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K954203 · Cisco Sales Corp. · Physical Medicine device
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Dec 1995
Decision
95d
Days
Class 1
Risk

K954203 is an FDA 510(k) clearance for the MASSAGER THERAPUTIC, ELECTRIC. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Cisco Sales Corp. (Torrance, US). The FDA issued a Cleared decision on December 11, 1995 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Cisco Sales Corp. devices

FDA 510(k) Submission Details - K954203

510(k) Number K954203 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 07, 1995
Decision Date December 11, 1995
Days to Decision 95 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 115d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

IRO Device Classification - Class 1, General Controls

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IRO Vibrator, Therapeutic

All 22
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K954203.
COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER
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K923238 · Conair Corp. · Feb 1994