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510(k) Data Aggregation
K Number
K163150Device Name
ViMove2
Manufacturer
DORSAVI LTD
Date Cleared
2017-07-14
(247 days)
Product Code
IKN, HCC, KQX
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
DORSAVI LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ViMove2 is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
Device Description
ViMove2 is a wireless electronic device used by healthcare professionals to accurately measure, record and analyze movement and muscle activity of the lower back. The device obiectively measures, records and analyzes angular movement and muscle activity.
Under the direction of the healthcare professional, the software quides the patient through a series of dynamic movements and static postures in standing and sitting positions. ViMove2 then measures the range of motion and muscle activity, streams the data live via BTLE to a host device, e.g. PC, tablet or smart phone, and generates a personalized assessment report including comparisons to normative values.
ViMove2 is comprised of the following key components:
- · 4 Wireless Sensors (2 movement and 2 muscle activity)
- · Disposable Application Pads for attaching sensors to the patient.
- · ViMove software package
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K Number
K142494Device Name
ViMove
Manufacturer
dorsaVi Ltd.
Date Cleared
2015-05-28
(265 days)
Product Code
IKN, HCC, KQX
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
dorsaVi Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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