Cleared Traditional

DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A (K051357) - FDA 510(k) Clearance

Also marketed or referenced as:
DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH

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

K051357 · Digitimer , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
119d
Days
Class 2
Risk

K051357 is an FDA 510(k) clearance for the DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Digitimer , Ltd. (Fort Lauderdale, US). The FDA issued a Cleared decision on September 20, 2005 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Digitimer , Ltd. devices

Submission Details

510(k) Number K051357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2005
Decision Date September 20, 2005
Days to Decision 119 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 148d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 26
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K051357.
SEN-4100 ELECTRIC STIMULATOR
K071969 · Nihon Kohden America, Inc. · Oct 2008
NEUROVISION JJB SYSTEM
K072343 · Nuvasive, Inc. · Oct 2007
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
K062765 · Nuvasive, Inc. · Jan 2007
MEE-1000A NEUROMASTER
K051178 · Nihon Kohden America, Inc. · Aug 2005
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K051384 · Nuvasive, Inc. · Jul 2005
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
K991899 · Nihon Kohden America, Inc. · Sep 1999