Cleared Traditional

K010209 - ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL

K010209 is an FDA 510(k) clearance for ELECTRO-NERVE STIMULATOR TENS, manufactured by Biomedical Life Systems, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K010209 · Biomedical Life Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
140d
Days
Class 2
Risk

K010209 is an FDA 510(k) clearance for the ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Biomedical Life Systems, Inc. (Vista, US). The FDA issued a Cleared decision on June 12, 2001 after a review of 140 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomedical Life Systems, Inc. devices

FDA 510(k) Submission Details - K010209

510(k) Number K010209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2001
Decision Date June 12, 2001
Days to Decision 140 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 149d · This submission: 140d
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 379
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K010209.
MICROSTIM 100I TENS DEVICE
K010295 · Microstim, Inc. · Aug 2001
WELL-TENS
K002874 · Well-Life Consultant · Jul 2001
MULTI-STIM, MODEL MS-100
K001897 · Metron Medical Australia, Pty, Ltd. · Jun 2001
TRANSAMERICAN TENS
K010782 · Transamerica Medical Systems · Apr 2001
YORAMED, MODEL T-202
K002297 · United Yoram Distributors, Inc. · Mar 2001
LIFECARE COMPACT TENS DEVICE
K003369 · Lifecare , Ltd. · Mar 2001