Cleared Traditional

K853163 - SETMA VHT

K853163 is an FDA 510(k) clearance for SETMA VHT, manufactured by Setma, Inc.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K853163 · Setma, Inc. · Physical Medicine device
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Nov 1985
Decision
98d
Days
Class 2
Risk

K853163 is an FDA 510(k) clearance for the SETMA VHT. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Setma, Inc. (Whitehouse, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5100 - 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 Setma, Inc. devices

FDA 510(k) Submission Details - K853163

510(k) Number K853163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date November 05, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILJ Device Classification - Class 2, Special Controls

Product Code ILJ Bath, Hydro-massage
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5100
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 - ILJ Bath, Hydro-massage

All 14
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K853163.
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
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SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
K971593 · The Silcraft Corp. · Feb 1998
BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
K964926 · Joerns Healthcare, Inc. · Nov 1997