Cleared Traditional

MOTO-MED RF-II AND PICO (K893924) - FDA 510(k) Clearance

Class I Physical Medicine device.

K893924 · Holl Meditronics, Inc. · Physical Medicine device
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Nov 1990
Decision
545d
Days
Class 1
Risk

K893924 is an FDA 510(k) clearance for the MOTO-MED RF-II AND PICO. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Holl Meditronics, Inc. (Collingswood, US). The FDA issued a Cleared decision on November 27, 1990 after a review of 545 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Holl Meditronics, Inc. devices

Submission Details

510(k) Number K893924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1989
Decision Date November 27, 1990
Days to Decision 545 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
430d slower than avg
Panel avg: 115d · This submission: 545d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
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.