Cleared Traditional

K951622 - VAX-D THERAPEUTIC TABLE

K951622 is an FDA 510(k) clearance for VAX-D THERAPEUTIC TABLE, 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 488-day FDA review.

K951622 · Vat-Tech, Inc. · Physical Medicine device
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Jul 1996
Decision
488d
Days
Class 2
Risk

K951622 is an FDA 510(k) clearance for the VAX-D THERAPEUTIC TABLE. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Vat-Tech, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on July 2, 1996 after a review of 488 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Vat-Tech, Inc. devices

FDA 510(k) Submission Details - K951622

510(k) Number K951622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1995
Decision Date July 02, 1996
Days to Decision 488 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
373d slower than avg
Panel avg: 115d · This submission: 488d
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 28
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K951622.
TM-300 TRACTION SYSTEM
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DRS SYSTEM
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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