Cleared Traditional

K944329 - BACK SPECIALIST (FDA 510(k) Clearance)

Class I Physical Medicine device.

K944329 · Health Care Mfg., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
75d slower than avg
Panel avg: 115d · This submission: 190d
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.