Cleared Traditional

K944699 - ATT-300

K944699 is an FDA 510(k) clearance for ATT-300, manufactured by Health Care Mfg., Inc.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 245-day FDA review.

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

FDA 510(k) Submission Details - K944699

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.

ITH Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K944699.
MTD 4000
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DYNATRON 900
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AKRON ATP9 TRACTION MACHINE
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EXCEL TX
K940200 · Excel Tech. , Ltd. · Jun 1994
RICH-MAR SPINA-MOBILIZOR
K861832 · Rich-Mar Corp. · Jun 1986
TRACTION 230
K830088 · Tri W-G, Inc. · Jan 1983