Cleared Traditional

K800749 - IPOCON 7

K800749 is an FDA 510(k) clearance for IPOCON 7, manufactured by Ipos Luneburg. The device is a Class 1 Physical Medicine device with product code ITG cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K800749 · Ipos Luneburg · Physical Medicine device
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Jul 1980
Decision
115d
Days
Class 1
Risk

K800749 is an FDA 510(k) clearance for the IPOCON 7. Classified as Bandage, Cast (product code ITG), Class I - General Controls.

Submitted by Ipos Luneburg (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3025 - 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 Ipos Luneburg devices

FDA 510(k) Submission Details - K800749

510(k) Number K800749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1980
Decision Date July 28, 1980
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

ITG Device Classification - Class 1, General Controls

Product Code ITG Bandage, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3025
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.