Cleared Traditional

K003596 - SMITH & NEPHEW RESTIM

K003596 is an FDA 510(k) clearance for SMITH & NEPHEW RESTIM, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K003596 · Smith & Nephew, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
197d
Days
Class 2
Risk

K003596 is an FDA 510(k) clearance for the SMITH & NEPHEW RESTIM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Germantown, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 197 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 - K003596

510(k) Number K003596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2000
Decision Date June 06, 2001
Days to Decision 197 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
81d slower than avg
Panel avg: 116d · This submission: 197d
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 547
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K003596.
EMS 3000
K010745 · Dan Med, Inc. · Jun 2001
NEURO-TRAIN III (3)
K003433 · Sterne Equipment Co., Ltd. · Jun 2001
FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
K002410 · Dysphagia, LLC · Jun 2001
VECTORSURGE 5, MODEL VS-500
K002058 · Metron Medical Australia, Pty, Ltd. · May 2001
TRANSAMERICA DIGITAL EMS
K010665 · Transamerica Medical Systems · Apr 2001
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
K003260 · Metron Medical Australia, Pty, Ltd. · Feb 2001
K003596 · SMITH & NEPHEW RESTIM
Download PDF FDA Summary Smith & Nephew, Inc.