Cleared Traditional

K924973 - DYLNAMEDICS A.S.A.P.

K924973 is an FDA 510(k) clearance for DYLNAMEDICS A.S.A.P., manufactured by Dynamedics, Inc.. The device is a Class 2 Physical Medicine device with product code INX cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K924973 · Dynamedics, Inc. · Physical Medicine device
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Oct 1993
Decision
380d
Days
Class 2
Risk

K924973 is an FDA 510(k) clearance for the DYLNAMEDICS A.S.A.P.. Classified as Bed, Air Fluidized (product code INX), Class II - Special Controls.

Submitted by Dynamedics, Inc. (Canada, N6b3n5, CA). The FDA issued a Cleared decision on October 15, 1993 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5160 - 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. Elevated predicate reliance profile. 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 Dynamedics, Inc. devices

FDA 510(k) Submission Details - K924973

510(k) Number K924973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date October 15, 1993
Days to Decision 380 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 115d · This submission: 380d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INX Device Classification - Class 2, Special Controls

Product Code INX Bed, Air Fluidized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5160
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - INX Bed, Air Fluidized

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