Cleared Traditional

K030537 - DIGI-PRO TENS/WL-2203B

K030537 is an FDA 510(k) clearance for DIGI-PRO TENS/WL-2203B, manufactured by Well-Life Healthcare, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K030537 · Well-Life Healthcare, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
28d
Days
Class 2
Risk

K030537 is an FDA 510(k) clearance for the DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Well-Life Healthcare, Inc. (Taichung, R.O.C., TW). The FDA issued a Cleared decision on March 20, 2003 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology 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 Well-Life Healthcare, Inc. devices

FDA 510(k) Submission Details - K030537

510(k) Number K030537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2003
Decision Date March 20, 2003
Days to Decision 28 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 151
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K030537.
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
K023916 · Bio-Medical Research, Ltd. · Apr 2004
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
K033455 · Biomedical Life Systems, Inc. · Jan 2004
NEUROTECH BAXOLVE TYPE 294
K023913 · Bio-Medical Research, Ltd. · Aug 2003
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
K022841 · Biomedical Life Systems, Inc. · Nov 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
K022925 · Biomedical Life Systems, Inc. · Nov 2002
DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
K020749 · Everyway Medical Instruments Co.,Ltd · Oct 2002