Compliance

View the information below for compliance documentation for Biodex Rehab

International Distributor Agreement
End User Statement
ISO Certification

ISO 13485 Certificate

Conformance to Standards
Balance System SD950-440, 950-441, 950-444, 950-450
Gait Trainer 3950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408
System 4 Pro, Quick-Set and MVP850-000, 840-000, 852-000
Declaration of Conformity
Balance System SD950-430, 950-440, 950-441, 950-444, 950-450
Gait Trainer 3950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408, 950-413
NxStep Unweighing System945-480, 950-484, 950-485
System 4 Pro850-000
System 4 MVP852-000
System 4 Quick-Set840-000
System 4 Attachment, Dual Position Roll-Up Back830-450
System 4 Attachment, Closed Chain830-520
System 4 Attachments, Pediatric850-830
System 4 Attachments, UE Hemiparetic830-540
System 4 Conversion Bundle 850-830
  
C-Arm Tables 

Table, Urology C-Arm – 800
Table, Brachytherapy C-Arm – 810
3D Imaging C-Arm – 820
Table, Surgical C-Arm – 840
Table, Surgical C-Arm – 846
Table, Pain Management C-Arm – 870

058-800, 058-805
058-810, 058-815
058-820, 058-825
058-840, 058-840-10, 058-845, 058-845-10
058-846, 058-846-10, 058-847, 058-847-10
058-870, 058-870-10, 058-875, 058-875-10

SDS, Safety Data Sheets
SDS, Treadmill Belt Lubricant945-276
SDS, Clear-Lead
MSDS, Monolite Battery056-862, 056-863, 058-800, 058-805, 058-810, 058-815, 058-820, 058-825, 058-840, 058-840-10, 058-845, 058-845-10, 058-878, 058-879, 945-480, 950-485