Cleared Traditional

K970429 - BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T

K970429 is an FDA 510(k) clearance for BIOSCOPE SD TENS, manufactured by Apex Medical Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K970429 · Apex Medical Corp. · Neurology device
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Apr 1997
Decision
84d
Days
Class 2
Risk

K970429 is an FDA 510(k) clearance for the BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW). The FDA issued a Cleared decision on April 29, 1997 after a review of 84 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 Apex Medical Corp. devices

FDA 510(k) Submission Details - K970429

510(k) Number K970429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1997
Decision Date April 29, 1997
Days to Decision 84 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
64d faster than avg
Panel avg: 148d · This submission: 84d
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 286
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K970429.
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K963507 · Comtek Intl., Corp. · Mar 1997