Cleared Traditional

K944277 - DYNAMO

K944277 is the FDA 510(k) clearance for DYNAMO by Pride Health Care, Inc.. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K944277 · Pride Health Care, Inc. · Physical Medicine device
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Dec 1994
Decision
120d
Days
Class 2
Risk

K944277 is an FDA 510(k) clearance for the DYNAMO. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Pride Health Care, Inc. (West Wyoming, US). The FDA issued a Cleared decision on December 28, 1994 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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 Pride Health Care, Inc. devices

Submission Details

510(k) Number K944277 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 30, 1994
Decision Date December 28, 1994
Days to Decision 120 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
5d slower than avg
Panel avg: 115d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
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 - INI Vehicle, Motorized 3-wheeled

All 80
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K944277.
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