CERTIFICATIONS

The Neuralign S™ is a medical device manufactured by NCS Lab srl. Regulatory approvals or registrations may still be under the name Shoulder Pacemaker in certain markets. 

NCS Lab is a certified company:

Certificate N.50 100 9205 UNI EN ISO 9001:2015
Certificate N. MED 29111 Rif: law 93/42 CEE
Certificate N. 8840-M UNI EN ISO 13485:2016
Regione Emilia Romagna Accreditation

The Shoulder Pacemaker device is FDA cleared via 510(k) number K210674 with the following intended use:

Shoulder Pacemaker is an electrotherapy device intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for Shoulder Pacemaker are:

• Prevention or retardation of disuse atrophy;
• Muscle re-education;
• Maintaining or increasing range of motion.

The device is intended for adults and adolescents age 14 and older.

Shoulder Pacemaker is a prescription device.

CAUTION: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.

The Shoulder Pacemaker device satisfies all the applicable regulatory requirements for the CE Marking of medical devices (EC MED 29111 certificate).

Contact Alyve Medical to confirm product availability in your country.

CONTACTS:

Global Customer Support and Sales

Alyve Medical 
600 S Cherry St, Ste 115
Denver, CO 80246 United States

Phone: +1 303-586-2444

Mail: info@alyvemedical.com 

Manufacturer of Record

NCS Lab srl 
Via Pola Esterna 4/12
41012 Carpi (MO) – Italy

Phone: +39 059 669813

Mail: info@ncs-company.com