Cleared Traditional

K052182 - SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.

K052182 is an FDA 510(k) clearance for SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S., manufactured by Shian Jia Meei Enterprise Co., Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K052182 · Shian Jia Meei Enterprise Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
86d
Days
Class 2
Risk

K052182 is an FDA 510(k) clearance for the SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Shian Jia Meei Enterprise Co., Ltd. (Flagstaff, US). The FDA issued a Cleared decision on November 4, 2005 after a review of 86 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 Shian Jia Meei Enterprise Co., Ltd. devices

FDA 510(k) Submission Details - K052182

510(k) Number K052182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2005
Decision Date November 04, 2005
Days to Decision 86 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
62d faster than avg
Panel avg: 148d · This submission: 86d
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 216
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