Cleared Traditional

K935061 - LOWER BODY CYCLES

K935061 is an FDA 510(k) clearance for LOWER BODY CYCLES, manufactured by Biodex Medical Systems, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K935061 · Biodex Medical Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
330d
Days
Class 1
Risk

K935061 is an FDA 510(k) clearance for the LOWER BODY 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 330 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.

FDA 510(k) Submission Details - K935061

510(k) Number K935061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1993
Decision Date September 16, 1994
Days to Decision 330 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 116d · This submission: 330d
Pathway characteristics
Predicate-based equivalence.

BXB Device Classification - Class 1, General Controls

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.

Regulatory Peers - BXB Exerciser, Powered

All 116
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K935061.
SWIMEX MULTIDEPTH POOL (MODEL 600T)
K935011 · Swimex Systems · Jan 1995
MULTILINK SHOULDER CPM UNIT
K935587 · Toronto Medical Corp. · Dec 1994
HYDROTRACK
K935509 · Ferno Ille · Oct 1994
SEMI-RECUMBENT CYCLES
K935216 · Biodex Medical Systems, Inc. · Sep 1994
UPPER BODY CYCLES (110 VOLT)/(220 VOLT)
K935520 · Biodex Medical Systems, Inc. · Sep 1994
ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD.
K933059 · Jace Systems, Inc. · Jun 1994
K935061 · LOWER BODY CYCLES
Download PDF FDA Summary Biodex Medical System…