Cleared Traditional

K821016 - QUADRUPLE JOGGER EXERCISER

K821016 is an FDA 510(k) clearance for QUADRUPLE JOGGER EXERCISER, manufactured by Industrial Energy Specialists, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K821016 · Industrial Energy Specialists, Inc. · Physical Medicine device
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Apr 1982
Decision
14d
Days
Class 1
Risk

K821016 is an FDA 510(k) clearance for the QUADRUPLE JOGGER EXERCISER. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Industrial Energy Specialists, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1982 after a review of 14 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K821016

510(k) Number K821016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1982
Decision Date April 26, 1982
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 116d · This submission: 14d
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 158
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K821016.
SUTTER CPM
K823539 · Sutter Biomedical, Inc. · Jan 1983
MOTORIZED EXERCISER
K822212 · W.R. Mccullin · Aug 1982
AUTORANGE MODEL 205
K822031 · Tri W-G, Inc. · Jul 1982
KEM-2
K820476 · Medical Graphics Corp. · Mar 1982
PATIENT GUIDED KNEE EXERCISER
K820120 · Richard'S Medical Equip., Inc. · Jan 1982
SUTTER CPM
K820083 · Sutter Biomedical, Inc. · Jan 1982
K821016 · QUADRUPLE JOGGER EXERCISER
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