Cleared Traditional

PERAMBULATOR (STROLLER) (K862888) - FDA 510(k) Clearance

Class I Physical Medicine device.

K862888 · Mednet, Inc. · Physical Medicine device
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Aug 1986
Decision
22d
Days
Class 1
Risk

K862888 is an FDA 510(k) clearance for the PERAMBULATOR (STROLLER). Classified as Stroller, Adaptive (product code LBE), Class I - General Controls.

Submitted by Mednet, Inc. (Battle Creek, US). The FDA issued a Cleared decision on August 13, 1986 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 Mednet, Inc. devices

Submission Details

510(k) Number K862888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1986
Decision Date August 13, 1986
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBE Stroller, Adaptive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
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.