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Pressure Therapy System

by Xiamen Senyang Co., Ltd China EUDAMED510(k)

Ref PT1002510(k) K192358 Product code IRPEMDN Z120607

Regulatory status

as of 26 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06952075702126 Basic UDI-DIDate28 Feb 2022RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK192358 Date23 Apr 2020ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Expiring

Certificates: none listed in EUDAMED

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1398-2023 FDA Class II initiated 7 Mar 2023

    Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication

Specification

EUDAMED · 510(k) · synced 25 Oct 2026

Device Name
Pressure Therapy System
Model / Reference
PT1002
Primary DI / UDI-DI
06952075702126, 06952075702287, 06952075702201, 06952075702294, 06952075702270, 06952075702331
Basic UDI-DI
B-06952075702126, B-06952075702287, B-06952075702201, B-06952075702294, B-06952075702270, B-06952075702331
EMDN Code
Z120607 Pneumatic compression equipment
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000018392
FDA applicant
Xiamen Senyang Co., Ltd.
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xiamen Senyang Co., Ltd

See all devices from Xiamen Senyang Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (7)

  • EUDAMED 8ffa7bfe-b46d-4e05-b297-6718d499ea2f 85 fields · synced 22 Oct 2026
  • EUDAMED 06952075702287|B-06952075702287 61 fields · synced 7 Oct 2026
  • EUDAMED 06952075702201|B-06952075702201 61 fields · synced 14 Oct 2026
  • EUDAMED 06952075702294|B-06952075702294 61 fields · synced 24 Oct 2026
  • EUDAMED 06952075702270|B-06952075702270 61 fields · synced 25 Oct 2026
  • EUDAMED 06952075702331|B-06952075702331 61 fields · synced 25 Oct 2026
  • FDA 510(k) K192358 1 fields · synced 18 May 2026