Cleared Traditional

AKUFON THERAPEUTIC MASSAGER (K850495) - FDA 510(k) Clearance

Class I Physical Medicine device.

K850495 · Jansson A/S · Physical Medicine device
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Jan 1986
Decision
329d
Days
Class 1
Risk

K850495 is an FDA 510(k) clearance for the AKUFON THERAPEUTIC MASSAGER. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Jansson A/S (Vejle, DK). The FDA issued a Cleared decision on January 3, 1986 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Jansson A/S devices

Submission Details

510(k) Number K850495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1985
Decision Date January 03, 1986
Days to Decision 329 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
214d slower than avg
Panel avg: 115d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 64
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K850495.
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB
K821633 · Fred Sammons, Inc. · Jun 1982
VIBRATOR
K810446 · Fred Sammons, Inc. · Mar 1981
BK-5203 FACILITATION VIBRATOR ELECTRIC
K800018 · Fred Sammons, Inc. · Jan 1980
HEAD FACILITATION VIBRATOR BK-5210
K771279 · Fred Sammons, Inc. · Aug 1977
ELECTRIC VIBRATOR
K761121 · Fred Sammons, Inc. · Dec 1976