Cleared Traditional

K830793 - PATIENT GUIDED ELBOW & SHOULDER EXERC (FDA 510(k) Clearance)

Class I Physical Medicine device.

K830793 · Richard'S Medical Equip., Inc. · Physical Medicine device
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Jun 1983
Decision
94d
Days
Class 1
Risk

K830793 is an FDA 510(k) clearance for the PATIENT GUIDED ELBOW & SHOULDER EXERC. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Richard'S Medical Equip., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983 after a review of 94 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Richard'S Medical Equip., Inc. devices

Submission Details

510(k) Number K830793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1983
Decision Date June 16, 1983
Days to Decision 94 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
21d faster than avg
Panel avg: 115d · This submission: 94d
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.