Cleared Traditional

K895977 - ACUSOURCE 600 (TENS)

K895977 is an FDA 510(k) clearance for ACUSOURCE 600 (TENS), manufactured by Microcurrent Research, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K895977 · Microcurrent Research, Inc. · Neurology device
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Jan 1990
Decision
89d
Days
Class 2
Risk

K895977 is an FDA 510(k) clearance for the ACUSOURCE 600 (TENS). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Microcurrent Research, Inc. (New Haven, US). The FDA issued a Cleared decision on January 9, 1990 after a review of 89 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 Microcurrent Research, Inc. devices

FDA 510(k) Submission Details - K895977

510(k) Number K895977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1989
Decision Date January 09, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
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 184
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K895977.
TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR
K896825 · Infrasonics Corp. · Nov 1990
MEGA-TENS DUAL CHANNEL T.E.N.S.
K903017 · Futuremed Div. of Future Impex Corp. · Oct 1990
NEUROTENS
K896620 · Henley Intl. · Apr 1990
DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
K895473 · Medical Devices, Inc. · Dec 1989
TTS2800
K895161 · Henley Intl. · Oct 1989
TTS2500
K895166 · Henley Intl. · Oct 1989