Cleared Traditional

NECKSAVER (K760644) - FDA 510(k) Clearance

Class I Physical Medicine device.

K760644 · Health Saver Corp. · Physical Medicine device
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Feb 1977
Decision
154d
Days
Class 1
Risk

K760644 is an FDA 510(k) clearance for the NECKSAVER. Classified as Orthosis, Cervical (product code IQK), Class I - General Controls.

Submitted by Health Saver Corp. (Mchenry, US). The FDA issued a Cleared decision on February 16, 1977 after a review of 154 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3490 - 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.

View all Health Saver Corp. devices

Submission Details

510(k) Number K760644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1976
Decision Date February 16, 1977
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IQK Orthosis, Cervical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3490
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.