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4 chamber sleeve 4CHSET

by Daesung Maref Co., Ltd.

Ref 4CHSETModel IPC-Sleeve, Extension zipper

4 chamber sleeve 4CHSET is an intermittent venous compression system (EU MDR Class I; FDA Class II; FDA product code IRP, Massager, Powered Inflatable Tube) made by Daesung Maref Co., Ltd., registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 880931567IPCSLEEVEEZQF), cleared under FDA 510(k) K202395 on 1 Sep 2021 (2 earlier submissions) and listed in FDA GUDID since 9 Mar 2023 (UDI-DI 08809802640368), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202395

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880931567IPCSLEEVEEZQF Basic UDI-DI 08809802640368UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809802640368 UDI-DI Date9 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202395 Date1 Sep 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880931567IPCSLEEVEEZQF registered 10 Sep 2026 Active
  • FDA 510(k) K202395 decided 1 Sep 2021 Active· +2 more in the status table
  • FDA GUDID UDI-DI 08809802640368 listed 9 Mar 2023 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K150033
  2. Cleared FDA 510(k) K203498
  3. Cleared FDA 510(k) K202395
  4. Listed FDA GUDID 08809802640368
  5. Registered EUDAMED 880931567IPCSLEEVEEZQF

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
4 chamber sleeve
Generic name
Intermittent venous compression system
Model / reference
4CHSET, IPC-Sleeve, Extension zipper
Primary DI / UDI-DI
08809802640368
Basic UDI-DI
880931567IPCSLEEVEEZQF
510(k) Number
FDA product code
IRP
EMDN code
Z12069080 Various physiotherapy and rehabilitation instruments - hardware accessories
GMDN term
Intermittent venous compression system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
890.5650
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
These are accessories for intermittent pneumatic compression (IPC) system to improve the blood circulation of patients. IPC-Sleeve is worn on the affected part of the patient and receives air pressure from the main device. Extension zipper is a product for expanding the size of the IPC-sleeve.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Intermittent venous compression system

Cleared under the same submission (K150033)

and 8 more cleared under K150033

Cleared under the same submission (K202395)

and 8 more cleared under K202395

Similar devices in this category

Other devices filed under VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Daesung Maref Co., Ltd.

See all devices from Daesung Maref Co., Ltd. →

Properties

  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)