Cleared Traditional

K090717 - FLEX-TENS

K090717 is an FDA 510(k) clearance for FLEX-TENS, manufactured by Emsi. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K090717 · Emsi · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
51d
Days
Class 2
Risk

K090717 is an FDA 510(k) clearance for the FLEX-TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Emsi (Alexandria, US). The FDA issued a Cleared decision on May 8, 2009 after a review of 51 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 Emsi devices

FDA 510(k) Submission Details - K090717

510(k) Number K090717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2009
Decision Date May 08, 2009
Days to Decision 51 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
97d faster than avg
Panel avg: 148d · This submission: 51d
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 167
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K090717.
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
K092448 · Hivox Biotek, Inc. · Mar 2010
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
K091317 · Bio-Medical Research, Ltd. · Jun 2009
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
K090922 · Empi · Jun 2009
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298
K082190 · Bio-Medical Research, Ltd. · Mar 2009
DX6605E-TENS, DX6605E-G, DX6609-G
K082057 · Shenzhen Dongdixin Technology Co., Ltd. · Feb 2009
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
K082011 · Bio-Medical Research, Ltd. · Nov 2008