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K Number
K022753
Device Name
REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
Manufacturer
MEDICAL DEVICE SERVICES
Date Cleared
2002-11-14

(87 days)

Product Code
JOW
Regulation Number
870.5800
Type
Traditional
Panel
CV
Reference & Predicate Devices
K012675
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Sequential compression sleeves are intended to increase venous comment contrallym in por as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients. Sequential compression sleeves are single patient use devices only

Device Description

Reprocessed Used Disposable Sequential Compression Sleeves

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) "substantially equivalent" letter from the FDA to a medical device manufacturer. It primarily discusses:

  • Device Identification: Reprocessed Used Disposable Sequential Compression Sleeves (K022753).
  • Regulatory Classification: Class II, Product Code JOW.
  • FDA Determination: The device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
  • Regulatory Requirements: General controls, good manufacturing practices, labeling, advertising, and other compliance aspects.
  • Intended Use Statement: "Sequential compression sleeves are intended to increase venous comment contrallym in por as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients. Sequential compression sleeves are single patient use devices only."

The letter explicitly states that "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." Substantial equivalence is determined by comparing the device to a predicate device, not necessarily by requiring the submission of new clinical or performance study data with specific acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the given text.

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).