Cleared Traditional

K964437 - GB-1002 TENS WITH MASSAGE

K964437 is an FDA 510(k) clearance for GB-1002 TENS WITH MASSAGE, manufactured by Skylark Device Co., Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 647-day FDA review.

K964437 · Skylark Device Co., Ltd. · Neurology device
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Aug 1998
Decision
647d
Days
Class 2
Risk

K964437 is an FDA 510(k) clearance for the GB-1002 TENS WITH MASSAGE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on August 14, 1998 after a review of 647 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 Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K964437

510(k) Number K964437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1996
Decision Date August 14, 1998
Days to Decision 647 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
499d slower than avg
Panel avg: 148d · This submission: 647d
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 153
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K964437.
ELECTRO-NERVE STIMULATOR TENS, MODEL LX
K990230 · Biomedical Life Systems, Inc. · Aug 1999
VECTRA STIM MODELS 200 AND 400
K982321 · Chattanooga Group, Inc. · Feb 1999
VECTRA PRO MODELS 2 AND 4
K982324 · Chattanooga Group, Inc. · Feb 1999
MICRO II MICROCURRENT TENS
K973978 · Apex Medical Corp. · Jul 1998
MULTI-STIM TENS, AP-101081T
K973979 · Apex Medical Corp. · Jul 1998
ACU-STIM TENS, AP-101082T
K973980 · Apex Medical Corp. · Jul 1998