Cleared Traditional

K963729 - SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)

K963729 is an FDA 510(k) clearance for SD-610M(ALSO KNOWN AS STANDARD TENS, 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 150-day FDA review.

K963729 · Skylark Device Co., Ltd. · Neurology device
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Feb 1997
Decision
150d
Days
Class 2
Risk

K963729 is an FDA 510(k) clearance for the SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD). 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 February 13, 1997 after a review of 150 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 Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K963729

510(k) Number K963729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date February 13, 1997
Days to Decision 150 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
1d slower than avg
Panel avg: 149d · This submission: 150d
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 378
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K963729.
EXTRA TENS (RI-2500) NEO TENS (RI-2000E)
K963507 · Comtek Intl., Corp. · Mar 1997
S.P. 100
K970696 · Lsi Intl., Inc. · Mar 1997
SHE-LI TENS STIMULATOR MODEL SL-101 RX
K961809 · Medi Consultants, Inc. · Feb 1997
M AND R REUSABLE ELECTRODES (MULTIPLE)
K963125 · M & R Mfg., Inc. · Feb 1997
ACTION POTENTIAL SIMULATION THERAPY DEVICE
K955470 · Neurotech, Inc. · Oct 1996
SMART-TENS, MODEL 456
K961376 · Bio-Medical Research, Ltd. · Sep 1996