Cleared Traditional

A.C. POWER PATIENT LIFT (K935351) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935351 · Ken Kemmerer · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
115d
Days
Class 2
Risk

K935351 is an FDA 510(k) clearance for the A.C. POWER PATIENT LIFT. Classified as Lift, Patient, Ac-powered (product code FNG), Class II - Special Controls.

Submitted by Ken Kemmerer (Wilkes Barre Twp, US). The FDA issued a Cleared decision on February 28, 1994 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5500 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ken Kemmerer devices

Submission Details

510(k) Number K935351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1993
Decision Date February 28, 1994
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 129d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FNG Lift, Patient, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5500
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 General Hospital devices follow this clearance model.