Cleared Traditional

K991835 - HANG UPS POWER II

K991835 is an FDA 510(k) clearance for HANG UPS POWER II, manufactured by Stl Intl., Inc.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K991835 · Stl Intl., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
206d
Days
Class 2
Risk

K991835 is an FDA 510(k) clearance for the HANG UPS POWER II. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Stl Intl., Inc. (Puyallup, US). The FDA issued a Cleared decision on December 20, 1999 after a review of 206 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 Stl Intl., Inc. devices

FDA 510(k) Submission Details - K991835

510(k) Number K991835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1999
Decision Date December 20, 1999
Days to Decision 206 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
91d slower than avg
Panel avg: 115d · This submission: 206d
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 15
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K991835.
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HEALTHSTAR ELITE
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DYNATRON 900
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AKRON ATP9 TRACTION MACHINE
K992733 · Huntleigh Technology, Inc. · Nov 1999
TM-300 TRACTION SYSTEM
K992545 · Ito Co., Ltd. · Sep 1999
CTD MARK I TRACTION DEVICE
K991931 · Therasys, Inc. · Aug 1999