Cleared Traditional

K944329 - BACK SPECIALIST

K944329 is an FDA 510(k) clearance for BACK SPECIALIST, manufactured by Health Care Mfg., Inc.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K944329 · Health Care Mfg., Inc. · Physical Medicine device
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Mar 1995
Decision
190d
Days
Class 1
Risk

K944329 is an FDA 510(k) clearance for the BACK SPECIALIST. 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 March 15, 1995 after a review of 190 days - an extended review 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: 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 Care Mfg., Inc. devices

FDA 510(k) Submission Details - K944329

510(k) Number K944329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1994
Decision Date March 15, 1995
Days to Decision 190 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
74d slower than avg
Panel avg: 116d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

INQ Device Classification - Class 1, General Controls

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.

Regulatory Peers - INQ Table, Powered

All 49
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