Cleared Traditional

K790652 - TOGUARD

K790652 is an FDA 510(k) clearance for TOGUARD, manufactured by Togard, Inc.. The device is a Class 1 Physical Medicine device with product code IPG cleared through the Traditional 510(k) pathway .

K790652 · Togard, Inc. · Physical Medicine device
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Apr 1979
Decision
-
Days
Class 1
Risk

K790652 is an FDA 510(k) clearance for the TOGUARD. Classified as Shoe, Cast (product code IPG), Class I - General Controls.

Submitted by Togard, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1979.

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.

FDA 510(k) Submission Details - K790652

510(k) Number K790652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1979
Decision Date April 04, 1979
Days to Decision -
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
Pathway characteristics
Predicate-based equivalence.

IPG Device Classification - Class 1, General Controls

Product Code IPG Shoe, 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.

K790652 · TOGUARD
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