Cleared Traditional

K991397 - TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS

K991397 is an FDA 510(k) clearance for TRANSCUTANEOUS ELECTRICAL NERVE STIMULA..., manufactured by Sein Electronics Co., Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K991397 · Sein Electronics Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
296d
Days
Class 2
Risk

K991397 is an FDA 510(k) clearance for the TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Sein Electronics Co., Ltd. (Buffalo Grove, US). The FDA issued a Cleared decision on February 11, 2000 after a review of 296 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.

View all Sein Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K991397

510(k) Number K991397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1999
Decision Date February 11, 2000
Days to Decision 296 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
148d slower than avg
Panel avg: 148d · This submission: 296d
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 251
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K991397.
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