Compliance

View the information below for compliance documentation for Sport Medical Rehab
Certificates to Foreign Government

FDA Certificate to Foreign Government – Physical Medicine

EC Certifications
International Distributor Agreement
End User Statement
ISO Certification

ISO 13485 Certificate

Conformance to Standards
Balance System SD 950-430, 950-440, 950-441, 950-444, 950-450
Gait Trainer 3 950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408, 950-413
System 4 Pro, Quick-Set and MVP 850-000, 840-000, 852-000
European Declaration of Conformity
Balance System SD 950-441
Gait Trainer 3 950-401, 950-403, 950-407
NxStep Unweighing System 945-480, 950-485
System 4 Pro 850-000
System 4 MVP 852-000
System 4 Quick-Set 840-000
System 4 Attachment, Dual Position Roll-Up Back 830-450
System 4 Attachment, Closed Chain 830-520
System 4 Attachments, Pediatric 850-830
System 4 Attachments, UE Hemiparetic 830-540
Vibrotactile System 950-430
SDS, Safety Data Sheets
SDS, Treadmill Belt Lubricant 945-276
SDS, Clear-Lead
MSDS, Monolite Battery 945-480, 950-485