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Device Explorer · FDA GUDID · GMDN 63558

Wearable sequential venous compression system

A noninvasive, electrically-powered, entirely patient-worn device assembly intended to improve venous and lymphatic return from the leg to help treat/prevent venous disorders/sequelae (e.g., swelling, pain, thrombosis). It consists of an electronic processor w

US‑registered devices84in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Koya Medical, Inc.7589%
Elastimed Ltd810%
Therma Bright Inc11%

Top labelers

CompanyDevicesShare
Koya Medical, Inc.7589%
Elastimed Ltd810%
Therma Bright Inc11%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MyoSleeveDAYSPRINGDAYSPRING ARM GARMENTDayspringKoya MedicalVenowave VW5

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
JOWSLEEVE, LIMB, COMPRESSIBLE79
JOWSleeve, Limb, Compressible9

GMDN & GCC registration

  • GMDN code 63558 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 93% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Gram) · 1Length (Millimeter) · 1Width (Millimeter) · 1Height (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many wearable sequential venous compression system products are registered in the US?

84 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Wearable sequential venous compression system", from 3 companies. The largest labeler is Koya Medical, Inc. with 89% of records.

Which FDA product codes apply?

JOW (SLEEVE, LIMB, COMPRESSIBLE), JOW (Sleeve, Limb, Compressible)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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