CERTIFICATIONS

The SHOULDER PACEMAKER™ system is a medical devices manufactured by NCS Lab srl.

• 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: The SHOULDER PACEMAKER™  system is an electrotherapy device intended for neuromuscular electrical stimulation (NMES).
  The Indications for Use for the SHOULDER PACEMAKER™ device are:
  -Prevention or retardation of disuse atrophy;
  -Muscle re-education;
  -Maintaining or increasing range of motion.The device is intended for adults only.The SHOULDER PACEMAKER™ device 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).

Please, contact your local representative to ask for product availability in your country.