Cleared Traditional

K781964 - COMPRESSION DEVICES

K781964 is the FDA 510(k) clearance for COMPRESSION DEVICES by Alba-Waldensian, Inc.. It is a Class 2 Physical Medicine device (product code IRP) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K781964 · Alba-Waldensian, Inc. · Physical Medicine device
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Dec 1978
Decision
22d
Days
Class 2
Risk

K781964 is an FDA 510(k) clearance for the COMPRESSION DEVICES, LIMB. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Alba-Waldensian, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 12, 1978 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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.

View all Alba-Waldensian, Inc. devices

Submission Details

510(k) Number K781964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1978
Decision Date December 12, 1978
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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.