Cleared Traditional

BIRDIE BRACKET (K872028) - FDA 510(k) Clearance

Class I Physical Medicine device.

K872028 · William W. Wilkerson & Gregory A. Knutson · Physical Medicine device
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Jul 1987
Decision
65d
Days
Class 1
Risk

K872028 is an FDA 510(k) clearance for the BIRDIE BRACKET. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by William W. Wilkerson & Gregory A. Knutson (St. Paul, US). The FDA issued a Cleared decision on July 31, 1987 after a review of 65 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 William W. Wilkerson & Gregory A. Knutson devices

Submission Details

510(k) Number K872028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1987
Decision Date July 31, 1987
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
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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