Cleared Traditional

K760644 - NECKSAVER

K760644 is an FDA 510(k) clearance for NECKSAVER, manufactured by Health Saver Corp.. The device is a Class 1 Physical Medicine device with product code IQK cleared through the Traditional 510(k) pathway after a 154-day FDA review.

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.

FDA 510(k) Submission Details - K760644

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
38d slower than avg
Panel avg: 116d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

IQK Device Classification - Class 1, General Controls

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.

K760644 · NECKSAVER
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