Cleared Traditional

K884210 - TX-7 (TENS) (IC-1107)

K884210 is an FDA 510(k) clearance for TX-7 (TENS) (IC-1107), manufactured by Oms Medical Supplies, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K884210 · Oms Medical Supplies, Inc. · Neurology device
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Dec 1988
Decision
67d
Days
Class 2
Risk

K884210 is an FDA 510(k) clearance for the TX-7 (TENS) (IC-1107). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Oms Medical Supplies, Inc. (Braintree, US). The FDA issued a Cleared decision on December 12, 1988 after a review of 67 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 Oms Medical Supplies, Inc. devices

FDA 510(k) Submission Details - K884210

510(k) Number K884210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date December 12, 1988
Days to Decision 67 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 148d · This submission: 67d
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 252
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K884210.
MODIFIED MRL NEUROPROBE SYSTEM V
K884869 · Medical Research Laboratories, Inc. · Jun 1989
EMPI, MODEL 489, TENS
K890604 · Empi · Jun 1989
MEDIMOD(TM), MODEL 8900
K890705 · Medical Devices, Inc. · Mar 1989
HEPAX (TENS)
K882154 · Avl Scientific Corp. · Sep 1988
EMPI MODEL 727,NMS
K882631 · Empi · Sep 1988
MEDIPAC II EC (TM), MODEL 7900
K882820 · Medical Devices, Inc. · Aug 1988