Cleared Traditional

K843637 - HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI

K843637 is an FDA 510(k) clearance for HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC..., manufactured by Therapeutic Equipment Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K843637 · Therapeutic Equipment Corp. · Neurology device
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Nov 1984
Decision
73d
Days
Class 2
Risk

K843637 is an FDA 510(k) clearance for the HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Therapeutic Equipment Corp. (Clifton, US). The FDA issued a Cleared decision on November 29, 1984 after a review of 73 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 Therapeutic Equipment Corp. devices

FDA 510(k) Submission Details - K843637

510(k) Number K843637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date November 29, 1984
Days to Decision 73 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 148d · This submission: 73d
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 287
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K843637.
ELECTRO-NERVE STIMULATOR B5/SK700B
K844076 · Biomedical Life Systems, Inc. · Jan 1985
STIMTECH SD CLINICIAN 6090 #78-8055
K844212 · Codman & Shurtleff, Inc. · Jan 1985
STIMTECH SD PATIENT 6089 #78-8050
K844213 · Codman & Shurtleff, Inc. · Jan 1985
ELECTRO-NERVE STIMULATOR HL
K841184 · Biomedical Life Systems, Inc. · Oct 1984
MENTOR 150 PLUS TRANSCUTANEOUS ELEC.
K842812 · Mentor Corp. · Aug 1984
NEURO PULSE
K841400 · Parker Laboratories, Inc. · Jun 1984