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510(k) Data Aggregation
K Number
K090921Device Name
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
Manufacturer
BEIERSDORF, INC.
Date Cleared
2009-12-18
(261 days)
Product Code
DWL
Regulation Number
880.5780Why did this record match?
Applicant Name (Manufacturer) :
BEIERSDORF, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anti-Embolism Stockings: Help prevent edema and leg discomfort, and help prevent deep vein thrombosis (DVT) in individuals subjected to immobility. Over-the-Counter (OTC) Use
Device Description
The Anti-Embolism Stockings are compression stockings consisting of 90% nylon and 10% spandex. The thigh length stockings have a silicone band at the top. Knee length and thigh length models are each provided in three (3) different sizes. The Anti-Embolism Stockings are designed for the post-operative patient. The knee and thigh length models of these anti-embolism stockings are produced on a circular knitting machine. Nylon varns are knit into the fabric structure while the nylon covered spandex yarns are in-laid into the fabric structure. The stockings are designed with the higher compression in the ankle region (18 mmHg) and lower, graduated compression in the calf (11 mmHg) and thigh regions (8 mmHg - thigh length model) of the leg. The mechanism of action is achieved via the graduated compression design. The Anti-Embolism Stockings are not made with natural rubber latex.
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K Number
K024057Device Name
CURAD SCAR THERAPY
Manufacturer
BEIERSDORF, INC.
Date Cleared
2003-06-18
(191 days)
Product Code
MDA
Regulation Number
878.4025Why did this record match?
Applicant Name (Manufacturer) :
BEIERSDORF, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for the management of hypertrophic and keloid scars. May be used as prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring.
Device Description
Curad® Scar Therapy is a semi-occlusive, flexible pad for the management of hypertrophic scars resulting from burns, surgery, or injuries, after complete healing. The device is also intended for management of keloid scars. It may be used as a prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring. It is intended for over-the-counter use.
Curad® Scar Therapy consists of an adhesive aliphatic polyurethane matrix. Embedded in this matrix are absorbent sodium polyacrylate particles. The product has a waterproof polyurethane film that is permeable to oxygen and water vapor.
The Curad® Scar Therapy pads are individually sealed in envelopes and packaged in cartons of 21 pads. The size of the pads is 7x4 cm. The pad is intended to be exchanged daily for a new pad, and may remain in place 24 hours a day. Treatment should consist of at least 12 hours a day for at least eight weeks.
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