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View FDA Letter Regarding Electrotherapy/Lead Wire Complaince

New Lead Wires Regulations

The FDA has mandated that by May 9, 2000, all patient leadwires must conform to new performance standards to protect patients from accidental exposure to an electrical energy source through the leadwires. (FDA 21 CFR Part 898 - IEC601-1, Part 1 amendments No. 1 and No. 2, General Requirement for Safety) This standard requires the originating end of the leadwire (the end attached to the device) be shielded.

You must purchase new compliant leadwires and/or adapters for all your electrical stimulation units to be compliant with this new federally mandated law. All manufacturers will be shipping new, compliant patient leadwires with new units after May 9, 2000.

BioMedical Life Compliant Lead Wires

Most units manufactured during from the year 2000 forward are compliant. There is no retrofit or upgrade to make units older than 2000 compliant with the new FDA standards. You must purchase a new compliant unit.  Contact HPMS, Inc. to verify compliance.  To purchase compliant lead wires go to BioMedical Life Systems Electrotherapy Equipment page.

Staodyn/Rehabilicare Compliant Lead Wires

Some units can be retrofitted to make old units compliant witht the new FDA standards.  In some case you must purchase a new unit.  Contact HPMS, Inc. to verify compliance.  To purchase compliant lead wires scroll down.

Chattanooga Group Compliant Lead Wires

Information coming soon!

$29.00/pair

Rehabilicare | Staodyn FDA Compliant Lead Wires
Leadwire, Safety, 36" - Pair
 
These lead wires are for FDA compliant units only.  They will not work with non-compliant units. 
 
To find out if your unit is compliant email HPMS, Inc. the model of the unit and serial number located inside the battery comparment.  

$30.00/pair

Rehabilicare | Staodyn FDA Compliant Lead Wires
Leadwire, Safety, 60" - Pair
 
These lead wires are for FDA compliant units only.  They will not work with non-compliant units. 
 
To find out if your unit is compliant email HPMS, Inc. the model of the unit and serial number located inside the battery comparment.  

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HPMS, Inc. dba The Therapy Connection 2006
128 Rockingham Rd Windham, NH 03087
T: 603-898-3909 Fax: 603-898-9348 
 

Please check in often because we will frequently update the product pages with new items.
 
Prices & Product Availability Subject to Change Without Notice. 
 
In order to offer you the widest selection of products, some items will ship directly from the manufacturer's warehouse and will be delivered to you within 7-10 business days.  Please note that to ensure proper delivery, a complete, physical address is required. You will receive a shipping confirmation for all items.
 
Any shipments outside the continental U.S. will be notified of any additional necessary shipping funds.  Free shipping offers are continental U.S. only, ground service. 

NOTE: FDA regulations require proof of professional status prior to HPMS dispensing electrotherapy devices. Electrotherapy Equipment orders will not be processed without proof of professional status.

HPMS, Inc. dba The Therapy Connection 2006 
128 Rockingham Rd Windham, NH 03087
T: 603-898-3909 Fax: 603-898-9348 E-mail:hpms@hpms.com
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