Cleared Traditional

THERAPEUTIC LIMB MANIPULATOR (K844118) - FDA 510(k) Clearance

Class I Physical Medicine device.

K844118 · Donald E. Redding · Physical Medicine device
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May 1985
Decision
206d
Days
Class 1
Risk

K844118 is an FDA 510(k) clearance for the THERAPEUTIC LIMB MANIPULATOR. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Donald E. Redding (Port Oxford, US). The FDA issued a Cleared decision on May 17, 1985 after a review of 206 days - an extended review 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: 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 Donald E. Redding devices

Submission Details

510(k) Number K844118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date May 17, 1985
Days to Decision 206 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
91d slower than avg
Panel avg: 115d · This submission: 206d
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.