Home › NCS LAB SRL › Shoulder Pacemaker device

Shoulder Pacemaker device

NCS LAB SRL · Model SPM01M1 · UDI-DI 08051122040902

IPF KQX HCC Prescription

510(k) clearances

678

Adverse events (1 deaths)

Recalls

174

Facilities

Description

The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or controlling it. The SPM01M1 configuration supports Bluetooth Low Energy communication. In this case it can connect directly to a smartphone/tablet on which a dedicated app is installed. The dedicated control software is supplied via an usb receiver and must be used by a properly trained healthcare professional.

Recalls

Date	Firm	Reason
2023-11-03	Liberty Medical Solutions, LLC	The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
2011-06-22	eSwallow USA LLC	It was discovered that the firm was distributing medical devices without FDA approval.
2009-01-25	Zynex Medical, Inc.	Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
2008-06-11	International Rehabilitative Sciences, Inc.	The charge current is leaking through two Diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operation, it then causes

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.