Sequential Pressure Cuff

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

510(k) Number

K771083 ↗

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 Gaymar Industries, Inc. →

• What is the Sequential Pressure Cuff used for?

  The Sequential Pressure Cuff is a compressible sleeve device designed for limb compression therapy. It functions by applying sequential pressure to promote blood flow and prevent stasis in the treated area, making it suitable for clinical use in managing circulation-related conditions.

• Is the Sequential Pressure Cuff sterile or non-sterile, and is it intended for single-use or reuse?

  The device is supplied non-sterile and is intended for reusable use in clinical settings. This means it must be cleaned and disinfected between uses according to institutional protocols, as it is not designed for single-use disposal.

• What regulatory classification and clearance does the Sequential Pressure Cuff have?

  The Sequential Pressure Cuff is classified as a Class II medical device under FDA regulation 870.5800 with product code JOW. It received traditional 510(k) clearance (K771083) on July 21, 1977, following a 35-day review, based on a determination of substantial equivalence.