Cleared Traditional

K951382 - HLT 406 (FDA 510(k) Clearance)

Class I Physical Medicine device.

K951382 · Health Care Mfg., Inc. · Physical Medicine device
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Jun 1995
Decision
66d
Days
Class 1
Risk

K951382 is an FDA 510(k) clearance for the HLT 406. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Health Care Mfg., Inc. (Springfield, US). The FDA issued a Cleared decision on June 1, 1995 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - 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 Health Care Mfg., Inc. devices

Submission Details

510(k) Number K951382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date June 01, 1995
Days to Decision 66 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
49d faster than avg
Panel avg: 115d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
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.