Cleared Traditional

K071093 - SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202

K071093 is an FDA 510(k) clearance for SAN SHIH POWERED MUSCLE STIMULATOR, manufactured by San Shih Electrical Enterprise Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K071093 · San Shih Electrical Enterprise Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
232d
Days
Class 2
Risk

K071093 is an FDA 510(k) clearance for the SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by San Shih Electrical Enterprise Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on December 6, 2007 after a review of 232 days - an extended review cycle.

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. Standard predicate reliance. 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 - K071093

510(k) Number K071093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2007
Decision Date December 06, 2007
Days to Decision 232 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 116d · This submission: 232d
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 490
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K071093.
MUSCLE PAIN DEVICE (MPD)
K073361 · Stevens Proof of Concept, Inc. · Mar 2008
VEINOPLUS NEUROMUSCULAR STIMULATOR
K072252 · Ad Rem Technology Sarl · Jan 2008
FD EMS, MODEL # D-FJ30E
K063642 · Fuji Dynamics Limited · Dec 2007
MODELS EMS 5.0, EMS 5.1
K072795 · Koalaty Products, Inc. · Nov 2007
GLOBUS GENESY 1100 STIMULATOR
K071431 · Domino S.R.L. · Sep 2007
EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311
K071320 · Everlife Medical Equipment Co., Ltd. · Aug 2007
K071093 · SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202
Download PDF FDA Summary San Shih Electrical E…