Cleared Traditional

K023347 - VITAL STIM

K023347 is an FDA 510(k) clearance for VITAL STIM, manufactured by Chattanooga Group. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K023347 · Chattanooga Group · Physical Medicine device
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Dec 2002
Decision
60d
Days
Class 2
Risk

K023347 is an FDA 510(k) clearance for the VITAL STIM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Chattanooga Group (Hixson, US). The FDA issued a Cleared decision on December 6, 2002 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K023347

510(k) Number K023347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2002
Decision Date December 06, 2002
Days to Decision 60 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 116d · This submission: 60d
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 422
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K023347.
MEDS-4 NEUROMUSCULAR STIMULATOR
K023439 · Medical Equipment Device Specialists · Jan 2003
MEDS-3 NEUROMUSCULAR STIMULATOR
K023446 · Medical Equipment Device Specialists · Jan 2003
PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000
K024036 · Johari Digital Healthcare , Ltd. · Dec 2002
ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M
K020130 · Rolor Electronics Corp. · Dec 2002
DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
K020750 · Everyway Medical Instruments Co.,Ltd · Oct 2002
EMS 400
K022493 · Body Clock Health Care, Ltd. · Oct 2002
K023347 · VITAL STIM
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