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510(k) Data Aggregation
K Number
K971046Device Name
HANDIFLEX
Manufacturer
Date Cleared
1997-09-16
(179 days)
Product Code
Regulation Number
890.5880Why did this record match?
Applicant Name (Manufacturer) :
HANDIFLEX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Handiflex is a tilt table which provide the means for the user to go from the horizontal to the near vertical position to access components for redeveloping muscles or increasing the range of motion of the joints.
The user can exercise different muscle groups at different degrees of inclination.
Device Description
Handiflex is a tilt table
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