Cleared Traditional

K051357 - DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A

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

K051357 is an FDA 510(k) clearance for DS7A CONSTANT CURRENT HIGH VOLTAGE STIM..., manufactured by Digitimer , Ltd.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K051357 · Digitimer , Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K051357

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 149d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

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 113
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K051357.
MAGSTIM 200-2
K060847 · Magstim Company Us, LLC · Sep 2006
ORTHOMON
K061113 · Axon Systems, Inc. · May 2006
MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
K051864 · The Magstim Company , Ltd. · Dec 2005
MEE-1000A NEUROMASTER
K051178 · Nihon Kohden America, Inc. · Aug 2005
ECLIPSE NEUROLOGICAL WORKSTATION
K050798 · Axon Systems, Inc. · Aug 2005
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K051384 · Nuvasive, Inc. · Jul 2005
K051357 · DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A
Download PDF FDA Summary Digitimer , Ltd.