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Ambulatory ADM, Unilateral incl. adapted footwear (pair)

Ambulatory ADM, Unilateral left or right, incl. adapted footwear (pair)
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A single Ambulatory ADM with a pair of adapted footwear. 

Comprises of:

One ADM device with a side clip system for attachment to footwear.
Footwear, typically a pair of adapted shoes. Depending on the requirement, one or both items of footwear will be modified to incorporate an “ADM Socket” which enables attachment of an ADM device.
Two ADM Removal Tools to enable removal of the ADM device from the footwear.

Please refer to ADM Modular System Overview for more details.

Shoes

Please note shoe selection is based on the foot length given. Typically, Reebok and New Balance trainers are used for shoes adapted for the ADM.

For sizing guidelines on these, please visit:
Reebok: https://www.reebok.co.uk/help-section-size_charts.html
New Balance: https://www.newbalance.co.uk/size-guide.html#kids-chart

 

REGULATORY DETAILS    
CE logo  

ADM Modular Brace System

EU Declaration of Conformity

Dorsi Ramp

EU Declaration of Conformity

UK CA logo  

ADM Modular Brace System

UK Declaration of Conformity

Dorsi Ramp

UK Declaration of Conformity

FDA logo  

Search the FDA Establishment Registration and Device Listing Database using

For C-Pro Direct:

Owner operator number:  10040405 or 

Registration number:  3009097552

For Kiddfoot:

Owner operator number:  10084074

Registration number:  3021014441

 

MHRA logo  

C-Pro Direct Ltd is a UK manufacturer of Medical Devices and is registered with the MHRA.  Registration number 5447.  Details of the registration are available on the MHRA Public Access Registration Database by searching for C-Pro Direct Ltd

 

Veritas Logo  

C-Pro Direct is certified by Bureau Veritas to the Medical Device Manufaturing Standard ISO 13485

Click here to download a copy of our registration

 

 

C-Pro Direct Ireland Limited is a wholly owned subsidiary of the UK company C-Pro Direct Ltd and is registered with the HPRA in Ireland as the Authorised Representative, Importer and Distributor for C-Pro Direct products.

 

EUDAMED Registrations

C-Pro Direct is registered on EUDAMED.  The details can be found on the EUDAMED public access database and searching using the Actor / SRN numbers given below.

 

C-Pro Direct Ltd (UK) is registered on EUDAMED as the Manufacturer with the Single Registration Number:

GB-MF-000025827

 

C-Pro Direct Ireland Limited is registered on EUDAMED as the Authorised Representative with the Single Registration Number:

IE-AR-000019792

 

C-Pro Direct Ireland Limited is registered on EUDAMED as the Importer with the Single Registration Number:

IE-IM-000023320