Cleared Traditional

K964434 - SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

K964434 is an FDA 510(k) clearance for SD-970EMS ELECTRICAL MUSCULAR STIMULATOR, manufactured by Skylark Device Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K964434 · Skylark Device Co., Ltd. · Physical Medicine device
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Oct 1997
Decision
338d
Days
Class 2
Risk

K964434 is an FDA 510(k) clearance for the SD-970EMS ELECTRICAL MUSCULAR STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on October 9, 1997 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K964434

510(k) Number K964434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1996
Decision Date October 09, 1997
Days to Decision 338 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 116d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 356
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K964434.
MODEL PS-1 PENA MUSCLE STIMULATOR
K980448 · Radionics, Inc. · Apr 1998
STELLAR MODEL HS-04
K973223 · Stellar Medical Corp. · Feb 1998
AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION
K972997 · Dan Med, Inc. · Nov 1997
W.M.E. GPS 1001
K961751 · Weaver Medical Electronics, Inc. · Sep 1997
IMPULSE HVG
K970847 · Armstrong Industries, Inc. · Sep 1997
MSI MAGNA-STYM
K972055 · Microvas Systems, Inc. · Aug 1997