Cleared Traditional

K973223 - STELLAR MODEL HS-04

K973223 is an FDA 510(k) clearance for STELLAR MODEL HS-04, manufactured by Stellar Medical Corp.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K973223 · Stellar Medical Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
175d
Days
Class 2
Risk

K973223 is an FDA 510(k) clearance for the STELLAR MODEL HS-04. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Stellar Medical Corp. (Rockville, US). The FDA issued a Cleared decision on February 18, 1998 after a review of 175 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 Stellar Medical Corp. devices

FDA 510(k) Submission Details - K973223

510(k) Number K973223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1997
Decision Date February 18, 1998
Days to Decision 175 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
60d slower than avg
Panel avg: 115d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 196
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K973223.
HAKOMED ELECDT/VACUPULLS
K980958 · Alive, Inc. · May 1998
ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
K980346 · Universal Technology Systems, Inc. · Apr 1998
MODEL PS-1 PENA MUSCLE STIMULATOR
K980448 · Radionics, Inc. · Apr 1998
AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION
K972997 · Dan Med, Inc. · Nov 1997
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
K964434 · Skylark Device Co., Ltd. · Oct 1997
IMPULSE HVG
K970847 · Armstrong Industries, Inc. · Sep 1997