> | Certificates to Foreign Government |
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> | 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 |
058-800, 058-805 |
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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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