Cleared Traditional

K821920 - I.C.E. BOX

K821920 is the FDA 510(k) clearance for I.C.E. BOX by Lhs Industries. It is a Class 2 Physical Medicine device (product code IRP) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K821920 · Lhs Industries · Physical Medicine device
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Aug 1982
Decision
64d
Days
Class 2
Risk

K821920 is an FDA 510(k) clearance for the I.C.E. BOX. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Lhs Industries (Mchenry, US). The FDA issued a Cleared decision on August 31, 1982 after a review of 64 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.

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Submission Details

510(k) Number K821920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1982
Decision Date August 31, 1982
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
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.