Cleared Traditional

PATIENT TURNING AND REPOSITIONING G DEV. (K770499) - FDA 510(k) Clearance

Class I General Hospital device.

K770499 · Patient Healthguards Corp. · General Hospital
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Apr 1977
Decision
46d
Days
Class 1
Risk

K770499 is an FDA 510(k) clearance for the PATIENT TURNING AND REPOSITIONING G DEV.. Classified as Device, Transfer, Patient, Manual (product code FMR), Class I - General Controls.

Submitted by Patient Healthguards Corp. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1977 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6785 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Patient Healthguards Corp. devices

Submission Details

510(k) Number K770499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1977
Decision Date April 29, 1977
Days to Decision 46 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 129d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMR Device, Transfer, Patient, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6785
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.