Model 5320 T.E.D. Compression Limb

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Modified Model 5320 T.E.D. Compression Limb

510(k) Number

K863581 ↗

FDA Product Code

JOW

Device Class

Class II

Regulation

21 CFR Part 870.5800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from The Kendal Co. →

• What is the primary clinical purpose of the Modified Model 5320 T.E.D. Compression Limb, and in which patient populations is it commonly used?

  The Modified Model 5320 T.E.D. Compression Limb is designed to apply graduated compression to the lower limb, helping to prevent deep vein thrombosis (DVT) by promoting venous return. It is typically used in postoperative patients or high-risk individuals where intermittent pneumatic compression is required to reduce the risk of blood clots.

• Is the Modified Model 5320 T.E.D. Compression Limb intended for reuse, or is it meant for single-use only?

  The device is explicitly labeled as a single-use limb sleeve, meaning it is not intended for reuse after one application. This is a standard practice for non-sterile compression sleeves to ensure patient safety and hygiene.

• Are there multiple sizes available for the Modified Model 5320 T.E.D. Compression Limb, and how would a clinician determine the correct fit for a patient?

  Yes, the device is available in various sizes, as indicated by the multiple registration numbers (e.g., 3029923680, 3009211636, etc.), which likely correspond to different limb circumferences or lengths. Clinicians should measure the patient’s lower limb and refer to the manufacturer’s sizing guidelines to select the appropriate size for a proper fit.

• How is the Modified Model 5320 T.E.D. Compression Limb regulated in the U.S., and what does this mean for healthcare providers?

  The device is regulated under the FDA’s 510(k) clearance process (K863581) and classified as a Class II medical device under regulation number 870.5800. This means it has undergone a premarket review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for use in clinical settings.

• Does the Modified Model 5320 T.E.D. Compression Limb require any special storage conditions, and is it sterile?

  The device is non-sterile and supplied as-is, meaning it does not require sterile storage conditions. However, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until use.