a division of AMREX-ZETRON, Inc.
a division of AMREX-ZETRON, Inc. |
|
| Patient Leads FDA Compliance | (800) 221-9069 |
AMREX is Ready
for the New Performance Standard for
Electrode Lead Wires and Patient Cables
FDA Compliance – Patient Leads
|
Amrex-Zetron Incorporated is pleased to announce that all electrotherapy devices and accessories we currently manufacture are compliant with the performance standard for electrode lead wires and patient cables, found in Title 21 Code of Federal Regulations (CFR), part 898. Amrex can upgrade units from the field to accommodate patient leads that comply with the FDA performance standard. The upgrade of these units requires the removal of all jacks designed for use with non-compliant patient leads and the modification of the device to install replacement jacks that accommodate compliant patient leads. In order to maintain original design specifications, Amrex does not authorize this device modification to be performed in the field. ATS (Amrex Technical Services) has developed a program to efficiently perform this service. |
Amrex®
Technical Services
Factory upgrade for Amrex®
field units to accommodate patient
leads that comply with the FDA performance standard
Pricing Schedule
Patient Leads
Excluded*
| Amrex Model | Standard Fee |
| MS322 | $ 88.55 |
| MS324A | $ 113.85 |
| MS324AB | $ 113.85 |
| HV752 | $ 113.85 |
| LVG325A | $ 113.85 |
| IF150 | $ 113.85 |
| IF250 | $ 113.85 |
| MC1000 | $ 113.85 |
| U/20 | Not Required |
| U/50 | Not Required |
| US/50 | $ 113.85 |
| US/54 | $ 113.85 |
| US/752 | $ 139.15 |
| U/HVG50 | $ 139.15 |
| Other Amrex Models | $ 113.85 - $ 189.75 |
|
* All patient leads that Amrex sells comply with the FDA Performance Standard for Electrode Lead Wires and Patient Cables. |
Federal law
(USA) restricts Amrex electrotherapy instruments to sale by
or on the order of a licensed practitioner
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a division of Amrex-Zetron, Inc.
641 East Walnut Street, Carson, California
90746
Telephone: (800) 221-9069 or (310)
527-6868
Fax: (310) 366-7343
Web Site: http://www.amrex-zetron.com
Copyright © 1998 Amrex-Zetron
Corporation. All rights reserved.
Last modified on May 1, 2008
Web Site Creator:
Produced and Maintained by Paul Elliott: Designer/Graphics
E-Mail: pkelliot@gte.net
Comments, suggestions welcome!