Cleared Traditional

K043239 - HEALTHSTAR ELITE

K043239 is an FDA 510(k) clearance for HEALTHSTAR ELITE, manufactured by Hill Laboratories Co.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K043239 · Hill Laboratories Co. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
29d
Days
Class 2
Risk

K043239 is an FDA 510(k) clearance for the HEALTHSTAR ELITE. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Hill Laboratories Co. (Frazer, US). The FDA issued a Cleared decision on December 22, 2004 after a review of 29 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.

View all Hill Laboratories Co. devices

FDA 510(k) Submission Details - K043239

510(k) Number K043239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2004
Decision Date December 22, 2004
Days to Decision 29 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 116d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
MARC M MOUSER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ITH Equipment, Traction, Powered

All 47
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K043239.
TRITON/TRU-TRAC/TX TRACTION DEVICES
K051938 · Chattanooga Group · Sep 2005
SPINEMED S200B/S200C
K051013 · Cert Health Sciences, LLC · Apr 2005
BASS ANTALGIC-TRAK
K042482 · Traction Masters, LLC · Mar 2005
EXTENTRAC ELITE
K031996 · Advanced Back Technologies · Jul 2004
SPINERX-LDM
K031862 · Spinerx Technology · Oct 2003
LORDEX POWER TRACTION EQUIPMENT
K031227 · Ever Prosperous Instrument, Inc. · Jul 2003

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.