Cleared Traditional

K944699 - ATT-300 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944699 · Health Care Mfg., Inc. · Physical Medicine device
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May 1995
Decision
245d
Days
Class 2
Risk

K944699 is an FDA 510(k) clearance for the ATT-300. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Health Care Mfg., Inc. (Springfield, US). The FDA issued a Cleared decision on May 26, 1995 after a review of 245 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - 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 K944699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1994
Decision Date May 26, 1995
Days to Decision 245 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
130d slower than avg
Panel avg: 115d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITH Equipment, Traction, Powered

All 70
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