Cleared Traditional

K021270 - ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2

K021270 is an FDA 510(k) clearance for ELECTRO-NERVE STIMULATOR TENS MODEL BML..., manufactured by Biomedical Life Systems. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K021270 · Biomedical Life Systems · Neurology device
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Feb 2003
Decision
290d
Days
Class 2
Risk

K021270 is an FDA 510(k) clearance for the ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Biomedical Life Systems (Vista, US). The FDA issued a Cleared decision on February 6, 2003 after a review of 290 days - an extended review 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: 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.

FDA 510(k) Submission Details - K021270

510(k) Number K021270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2002
Decision Date February 06, 2003
Days to Decision 290 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
141d slower than avg
Panel avg: 149d · This submission: 290d
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 589
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K021270.
ELFCARE DEVICE, MODELS 314A THROUGH 314G
K023231 · Mediseb , Ltd. · Apr 2003
DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B
K030537 · Well-Life Healthcare, Inc. · Mar 2003
DUOMED, SERIES 500, (MODELS ID 500, FL 500)
K030140 · Duomed, Inc. · Mar 2003
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3
K021271 · Biomedical Life Systems · Feb 2003
TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING)
K021794 · Tatung Co. · Jan 2003
MEDS-4 NEUROMUSCULAR STIMULATOR
K023435 · Medical Equipment Device Specialists · Jan 2003
K021270 · ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2
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