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510(k) Data Aggregation
K Number
K143458Device Name
Neurosplint
Manufacturer
Neurospectrum LLC
Date Cleared
2015-08-13
(252 days)
Product Code
IQI, ILH
Regulation Number
890.3475Why did this record match?
Applicant Name (Manufacturer) :
Neurospectrum LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An orthosis worn on the wrist
With rigid insert:
to limit wrist motion while worn, allowing the body to recover from the damage of repetitive motion or other injuries
to immobilize and / or support for functional improvement following, repetitive motion-type of injuries such as carpal tunnel syndrome (CTS), wrist strains or sprains, and similar injuries of the wrist
Without rigid insert:
- . to provide wrist support
- . to provide temporary relief of associated symptoms of some repetitive motion wrist conditions
- to provide feedback to the user when the wrist reaches maximal flexion or extension
Device Description
An orthosis worn on the wrist
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