Cleared Traditional

K935216 - SEMI-RECUMBENT CYCLES (FDA 510(k) Clearance)

Class I Physical Medicine device.

K935216 · Biodex Medical Systems, Inc. · Physical Medicine device
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Sep 1994
Decision
325d
Days
Class 1
Risk

K935216 is an FDA 510(k) clearance for the SEMI-RECUMBENT CYCLES. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Biodex Medical Systems, Inc. (Shirley, US). The FDA issued a Cleared decision on September 16, 1994 after a review of 325 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: 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 Biodex Medical Systems, Inc. devices

Submission Details

510(k) Number K935216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1993
Decision Date September 16, 1994
Days to Decision 325 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 115d · This submission: 325d
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.