Search Results
Found 1 results
510(k) Data Aggregation
K Number
K060150Device Name
SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
Manufacturer
ANDANTE MEDICAL DEVICES LTD.
Date Cleared
2006-02-23
(34 days)
Product Code
IRN
Regulation Number
890.5575Why did this record match?
Applicant Name (Manufacturer) :
ANDANTE MEDICAL DEVICES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmartStep™ System/ SmartStep™ Clinic System is intended to sense the amount of weight applied to the planter surface of the foot during rehabilitation. The System alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStep™ System/ SmartStep™ Clinic System is intended to be used in any situation in which therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
Device Description
The SmartStep™ System is a monitoring & biofeedback system for gait. The device is a tool, which is intended to assist the clinicians to accurately assess patients who are undergoing weight bearing restrictions and gait therapy training. The SmartStep™ is used to measure the amount of weight being applied to an affected limb, to teach and promote specific weight bearing skills and to test patient's ability to maintain a weight bearing range. The SmartStep™ system is to be used under the supervision of physician or licensed health care provider such as physiotherapist. The SmartStep™ System is comprised of the following three main subelements: Flexible Insole that is placed in the patient's shoe, acting as a pressure-sensing element. Control Unit, connected to PC Software. PC Software that acts as a patient medical record and patient assessment tool. A Manual Pump is used to inflate the Insole compartments.
Ask a Question
Page 1 of 1