Cleared Traditional

AGILANCE-GOLDEN SPOONS (K936178) - FDA 510(k) Clearance

Class I Physical Medicine device.

K936178 · Oismuller & Partner Keg · Physical Medicine device
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Jan 1995
Decision
387d
Days
Class 1
Risk

K936178 is an FDA 510(k) clearance for the AGILANCE-GOLDEN SPOONS. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Oismuller & Partner Keg (Austria, AT). The FDA issued a Cleared decision on January 18, 1995 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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: 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 Oismuller & Partner Keg devices

Submission Details

510(k) Number K936178 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 27, 1993
Decision Date January 18, 1995
Days to Decision 387 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
272d slower than avg
Panel avg: 115d · This submission: 387d
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

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