DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator, Model DS7AH

FDA 510(k) K051357 · Digitimer , Ltd.

Substantially Equivalent

510(k) numberK051357

Submission

Device name
DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator, Model DS7AH
Applicant
Digitimer , Ltd.
Fort Lauderdale, FL, US
Received
May 24, 2005
Decision date
September 20, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWF – Stimulator, Electrical, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1870
Specialty
Neurology

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K243982Nicolet EDXGWF · Special Natus Neurology Incorporated01/22/2025SE
K243495Natus Ultrapro S100 (982A0594)GWF · Special Natus Neurology Incorporated12/12/2024SE
K242345Delphi StimulatorGWF · Traditional Quantalx Neuroscience11/05/2024SE
K234092SafeOp 3: Neural Informatix SysteemGWF · Traditional Alphatec Spine, Inc.04/19/2024SE
K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional Soterix Medical, Inc.03/25/2024SE
K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special Inomed Medizintechnik GmbH10/27/2023SE
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K213849SafeOp 2: Neural Informatix SystemGWF · Traditional Alphatec Spine, Inc.03/09/2022SE

More from Alphatec Spine, Inc.

510(k)DeviceDecision
K172381Digitimer DS7AP Constant Current StimulatorIPF · Traditional 03/06/2018SE

Questions and answers

When was DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator, Model DS7AH cleared by the FDA?

DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator, Model DS7AH (K051357) received a 510(k) decision of Substantially Equivalent on September 20, 2005, 119 days after the submission was received.

What is the product code of K051357?

The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.