Cleared Traditional

SMART WAVE GS100 (K950617) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950617 · Shotwell & Carr, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
245d
Days
Class 2
Risk

K950617 is an FDA 510(k) clearance for the SMART WAVE GS100. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Shotwell & Carr, Inc. (Dallas, US). The FDA issued a Cleared decision on October 13, 1995 after a review of 245 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.

View all Shotwell & Carr, Inc. devices

Submission Details

510(k) Number K950617 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 10, 1995
Decision Date October 13, 1995
Days to Decision 245 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 115d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 73
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K950617.
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
K171978 · Shenzhen Dongdixin Technology Co., Ltd. · Oct 2017
HPM-6000
K160992 · BTL Industries, Inc. · Oct 2016
SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992
MYOCARE PLUS DUAL CHANNEL STIMULATOR
K851046 · 3M Company · Jul 1985