Shoulder Pacemaker
FDA 510(k)Class II (US FDA 510(k))
by Ncs Lab Srl
Identifiers
- 510(k) Number
- K210674 FDA 510(k)
- FDA Product Code
- IPF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Shoulder Pacemaker is a device designed to help restore proper shoulder function, with applicability in rehabilitation related to pathology or surgery. It is classified under the product code IPF. The device is manufactured by NCS Lab Srl.
The Shoulder Pacemaker is supplied by NCS Lab Srl, with authorizations including FDA 510K. The device has a unique k number, K210674, and is associated with the advisory committee for Physical Medicine. The manufacturer is based in Italy, with certifications including UNI EN ISO 9001:2015 and UNI EN ISO 13485:2016.
Frequently asked questions
What is the Shoulder Pacemaker used for?
The Shoulder Pacemaker is used to help restore proper shoulder function, particularly in rehabilitation related to pathology or surgery.
Is the Shoulder Pacemaker supplied sterile?
The device data does not specify sterility, but it is manufactured with certifications including UNI EN ISO 13485:2016, which ensures quality management for medical devices.
What is the regulatory authorization for the Shoulder Pacemaker?
The Shoulder Pacemaker has FDA 510K authorization, with a unique k number, K210674, indicating substantial equivalence to existing devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PRODUCT Information - Shoulder Pacemaker, Ncs - Showmotion + Shoulder Pacemaker, Ncs - Showmotion + Shoulder Pacemaker, NCS - Shoulder Pacemaker™
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210674 | Class II | Active |
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Manufacturer
- Manufacturer
- Ncs Lab Srl
Sources (1)
- FDA 510(k) K210674 24 fields · synced Sep 25, 2026