Cleared Traditional

K020314 - DIGI-PRO TENS

K020314 is an FDA 510(k) clearance for DIGI-PRO TENS, manufactured by Well-Life Healthcare, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020314 · Well-Life Healthcare, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
90d
Days
Class 2
Risk

K020314 is an FDA 510(k) clearance for the DIGI-PRO TENS, MODEL WL-2204 AND WL-2205. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Well-Life Healthcare, Inc. (Taichung, R.O.C., TW). The FDA issued a Cleared decision on April 30, 2002 after a review of 90 days - within the typical 510(k) review window.

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 Well-Life Healthcare, Inc. devices

FDA 510(k) Submission Details - K020314

510(k) Number K020314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2002
Decision Date April 30, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 167
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K020314.
NEUROTECH MEDISTIM PLUS, TYPE 291
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300 PV COMPLETE ELECTROTHERAPY SYSTEM
K021100 · Empi · Jun 2002
MODIFICATION TO: WINNER ST-2 STIMULATOR
K013770 · Rich-Mar Corp. · Jan 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K013771 · Rich-Mar Corp. · Jan 2002
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
K010749 · Biomedical Life Systems, Inc. · Sep 2001