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510(k) Data Aggregation
K Number
K072064Device Name
GRAVILAX TRACTION SYSTEM
Manufacturer
THERAPEUTIC CLINICAL TECHNOLOGIES, INC.
Date Cleared
2008-04-21
(269 days)
Product Code
ITH
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
THERAPEUTIC CLINICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GraviLax Traction System is intended for use in exerting therapeutic pulling forces on the patient's body. The device utilizes a cylindrical hot tub in which the patient is suspended vertically by a shoulder harness and which contains salt water whose salinity is adjusted to a specific gravity of approximately 1.2 providing an increased natural buoyancy to the user's body. Decompressive force (unloading due to distraction and positioning) to the sacral, lumbar and thoracic spine is achieved by application of suitable weights to the patient's ankles This device is for prescription use only and is limited to use by qualified personnel in a suitably equipped treatment facility.
Device Description
The device is a powered traction device pursuant to 21 CFR 890.5900 (FDA product code ITH) class 2. The device is substantially equivalent to various other traction devices which achieve their effect through the force of gravity and/or mechanical means.
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K Number
K010680Device Name
CT SPACER
Manufacturer
CLINICAL TECHNOLOGIES, INC.
Date Cleared
2001-05-23
(77 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
CLINICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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