Cleared Traditional

K993229 - ANALGESIC PULSER, MODEL AP-439

K993229 is an FDA 510(k) clearance for ANALGESIC PULSER, manufactured by Johari Electro-Tech Co.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 494-day FDA review.

K993229 · Johari Electro-Tech Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
494d
Days
Class 2
Risk

K993229 is an FDA 510(k) clearance for the ANALGESIC PULSER, MODEL AP-439. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Johari Electro-Tech Co. (Jodhpur-342003, IN). The FDA issued a Cleared decision on February 2, 2001 after a review of 494 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Johari Electro-Tech Co. devices

FDA 510(k) Submission Details - K993229

510(k) Number K993229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1999
Decision Date February 02, 2001
Days to Decision 494 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
346d slower than avg
Panel avg: 148d · This submission: 494d
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 227
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