Cleared Traditional

K902822 - MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE

K902822 is an FDA 510(k) clearance for MEDICAL DESIGNS, manufactured by Medical Design & Manufacturing Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K902822 · Medical Design & Manufacturing Corp. · Neurology device
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Dec 1990
Decision
175d
Days
Class 2
Risk

K902822 is an FDA 510(k) clearance for the MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medical Design & Manufacturing Corp. (Westerville, US). The FDA issued a Cleared decision on December 19, 1990 after a review of 175 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 Medical Design & Manufacturing Corp. devices

FDA 510(k) Submission Details - K902822

510(k) Number K902822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1990
Decision Date December 19, 1990
Days to Decision 175 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 148d · This submission: 175d
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 291
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K902822.
MC II (TM), MODEL 7200S
K903161 · Medical Devices, Inc. · Mar 1991
DYNATRON 200 MICROCURRENT
K903577 · Dynatronics Corp. · Mar 1991
SYNAPS (TM)
K903828 · Henley Intl. · Jan 1991
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