Cleared Traditional

K071869 - TENS/IF 14

K071869 is an FDA 510(k) clearance for TENS/IF 14, manufactured by Emsi. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K071869 · Emsi · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
245d
Days
Class 2
Risk

K071869 is an FDA 510(k) clearance for the TENS/IF 14. 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 March 7, 2008 after a review of 245 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 - K071869

510(k) Number K071869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2007
Decision Date March 07, 2008
Days to Decision 245 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 149d · This submission: 245d
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 383
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K071869.
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DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB
K071878 · Med-Lectric Corporation · Dec 2007