Cleared Traditional

K791866 - STANDARD HEALTH BIKE MODEL 019

K791866 is the FDA 510(k) clearance for STANDARD HEALTH BIKE MODEL 019 by Battle Creek Equipment Co.. It is a Class 2 Physical Medicine device (product code ISD) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K791866 · Battle Creek Equipment Co. · Physical Medicine device
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Oct 1979
Decision
13d
Days
Class 2
Risk

K791866 is an FDA 510(k) clearance for the STANDARD HEALTH BIKE MODEL 019. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Battle Creek Equipment Co. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1979 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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 Battle Creek Equipment Co. devices

Submission Details

510(k) Number K791866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1979
Decision Date October 04, 1979
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ISD Exerciser, Measuring

All 16
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K791866.
R1361 & R1372 MEASURED EXERCISE EQUIPMENT
K861348 · Tri W-G, Inc. · May 1986
NUCLEAR STRESS TABLE (NST-1)
K800892 · Technicare Corp. · May 1980
STRESS TABLE/ERGOMETER SYSTEM
K792591 · Victoreen, Inc. · Jan 1980
AUTORANGE
K781997 · Tri W-G, Inc. · Jan 1979
MODEL 880 REHABILITATION TRAINER
K770234 · Quinton, Inc. · Feb 1977
CALIBRATED GRASPING TUBES
K770148 · Maddak, Inc. · Feb 1977