Cleared Traditional

K770032 - PAGE TURNER

K770032 is an FDA 510(k) clearance for PAGE TURNER, manufactured by Possum, Inc.. The device is a Class 1 Physical Medicine device with product code ILP cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K770032 · Possum, Inc. · Physical Medicine device
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Jan 1977
Decision
6d
Days
Class 1
Risk

K770032 is an FDA 510(k) clearance for the PAGE TURNER. Classified as System, Communication, Non-powered (product code ILP), Class I - General Controls.

Submitted by Possum, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1977 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3700 - 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 - K770032

510(k) Number K770032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1977
Decision Date January 12, 1977
Days to Decision 6 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
110d faster than avg
Panel avg: 116d · This submission: 6d
Pathway characteristics
Predicate-based equivalence.

ILP Device Classification - Class 1, General Controls

Product Code ILP System, Communication, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3700
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.

K770032 · PAGE TURNER
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