Data / Medical devices / China / Arjo (Suzhou) Co., Ltd.
Arjo (Suzhou) Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 3 510(k) clearances
Arjo (Suzhou) Co., Ltd. is registered with the FDA (registration 3005619970) in Suzhou Jiangsu, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 23, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005619970
- Address
- No. 158 Fangzhou Road SIP, Suzhou, Jiangsu, Suzhou Jiangsu, China, 215024
- Owner or operator
- ARJOHUNTLEIGH AB (8010077)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- August 15, 2002
- Registered through
- 2026
- Brand names listed
- ACER PORTABLE LATERAL ROTATION SYSTEM (POZNAN - SPEC.DEVELOPER & POZNAN - COMPLAINTS), ALPHA RESPONSE MATTRESS (POZNAN - SPEC. DEVELOPER, POZNAN - COMPLAINTS), ALPHA RESPONSE PUMP (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS), ALPHA TRANCELL DELUXE PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS), ATMOSAIR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS), ATMOSAIR 9000A (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS), ATMOSAIR 9000AR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS), ATMOSAIR APOD (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 23, 2015 | K143438 | Flowtron ACS900 | JOW | Substantially Equivalent | Getinge (Suzhou) Co., Ltd. | accessdata.fda.gov |
| February 28, 2014 | K133119 | FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS | JOW | Substantially Equivalent | Arjohuntleigh Polska SP Z.O.O. | accessdata.fda.gov |
| March 26, 2002 | K010744 | FLOWTRON UNIVERSAL, MODEL AC600 | JOW | Substantially Equivalent | Huntleigh Healthcare, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 15, 2021 | 87752 | Class II | Terminated | Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system | There is a potential for abnormal inflation of the mattress. | accessdata.fda.gov |
Compare with other makers
Updated June 23, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.