Compliance

[1]

> Certificates to Foreign Government
> Conformance to Standards
> Declarations of Conformity
> EC Certifications
> International Distributor Agreement
> ISO Certification
> SDS, Safety Data Sheets

 


 

CERTIFICATES TO FOREIGN GOVERNMENT
FDA Certificate to Foreign Government – Physical Medicine [2]
FDA Certificate to Foreign Government – Radiology [3]

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CONFORMANCE TO STANDARDS
Balance System SD [4] 950-440, 950-441, 950-444, 950-450
Gait Trainer 3 [5] 950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408
System 4 Pro, Quick-Set and MVP [6] 850-000, 840-000, 852-000

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DECLARATION OF CONFORMITY
Balance System SD [7] 950-430, 950-440, 950-441, 950-444, 950-450
Gait Trainer 3 [8] 950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408, 950-413
NxStep Unweighing System [9] 945-480, 950-484, 950-485
System 4 Pro [10] 850-000
System 4 MVP [11] 852-000
System 4 Quick-Set [12] 840-000
System 4 Attachment, Dual Position Roll-Up Back [13] 830-450
System 4 Attachment, Closed Chain [14] 830-520
System 4 Attachments, Pediatric [15] 850-830
System 4 Attachments, UE Hemiparetic [16] 830-540
System 4 Conversion Bundle [17]  850-830
   
C-Arm Tables [1]  

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


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EC CERTIFICATIONS
EC Certificate Number 41312068-01 [18]
EC Certificate Number 41313009-01 [19]

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INTERNATIONAL DISTRIBUTOR AGREEMENT
End User Statement [20]

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ISO CERTIFICATION
ISO 13485 Certificate [21]

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SDS, SAFETY DATA SHEETS
SDS, Treadmill Belt Lubricant [22] 945-276
SDS, Clear-Lead [23] --
MSDS, Monolite Battery [24] 056-862, 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

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