Cleared Traditional

K894435 - VAX-T PELVIC TRACTION BELT

K894435 is an FDA 510(k) clearance for VAX-T PELVIC TRACTION BELT, manufactured by Vat-Tech, Inc.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K894435 · Vat-Tech, Inc. · Physical Medicine device
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Aug 1989
Decision
14d
Days
Class 2
Risk

K894435 is an FDA 510(k) clearance for the VAX-T PELVIC TRACTION BELT. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Vat-Tech, Inc. (Toronto Ont. M8z 1j7, CA). The FDA issued a Cleared decision on August 3, 1989 after a review of 14 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K894435

510(k) Number K894435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date August 03, 1989
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 116d · This submission: 14d
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 70
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K894435.
JT-1 POWERED TRACTION UNIT
K923103 · Chirotronics, Inc. · Nov 1992
ULTRA-TRAC
K900575 · Practical Healthcare Devices, Inc. · May 1990
DISTRAC(TM) TABLE
K900475 · Lossing Orthopedic, Inc. · May 1990
TRU TRAC TRACTION TABLE
K893448 · Tru-Trac · Jun 1989
SPINALATOR JS-1100 TRACTION UNIT
K893168 · The Spinalator Co. · May 1989
ULTRA TRACTION
K881603 · Component Equipment Mfg., Inc. · May 1988
K894435 · VAX-T PELVIC TRACTION BELT
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