Cleared Traditional

K850771 - OSTER MASSAGE WAND STICK MASSAGER 295-07

K850771 is the FDA 510(k) clearance for OSTER MASSAGE WAND STICK MASSAGER 295-07 by Daito Electric Machine Industries Company, Ltd.. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K850771 · Daito Electric Machine Industries Company, Ltd. · Physical Medicine device
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May 1985
Decision
78d
Days
Class 1
Risk

K850771 is an FDA 510(k) clearance for the OSTER MASSAGE WAND STICK MASSAGER 295-07. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Daito Electric Machine Industries Company, Ltd. (Milwaukee, US). The FDA issued a Cleared decision on May 14, 1985 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Daito Electric Machine Industries Company, Ltd. devices

Submission Details

510(k) Number K850771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1985
Decision Date May 14, 1985
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
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 - ISA Massager, Therapeutic, Electric

All 15
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K850771.
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