Data / Medical devices / Dominican Republic / Arjo Dominican Republic
Arjo Dominican Republic: FDA-registered device maker in Itabo, Haina San Cristobal, Dominican Republic, 1 510(k) clearance
Arjo Dominican Republic is registered with the FDA (registration 3012292104) in Itabo, Haina San Cristobal, Dominican Republic. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 11, 1996. 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
- 3012292104
- Address
- Building 9 PIISA Industrial Park Km. 18 1/2 Antigua Carretera Sanchez, Itabo, Haina San Cristobal, Dominican Republic, 10903
- Owner or operator
- ArjoHuntleigh AB (10051620)
- Roles
- Manufacturer
- First device listed
- April 12, 2016
- Registered through
- 2026
- Brand names listed
- ACTIVE AND REPOSITIONING SLINGS, AIRPAL DISPOSABLE SLING MATTRESS, AIRPAL TRANSFER MATTRESS, Arjo Disposable Slide Tube, Arjo Disposable Slide sheets, DISPOSABLE REPOSITIONING SLING, DVT30, DVT40 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Transfer | IKX | 1 | Manufacturer | accessdata.fda.gov |
| Bed, Flotation Therapy, Powered | IOQ | 2 | Manufacturer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Manufacturer | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 11, 1996 | K961166 | FLOWTRON EXCEL PUMP | JOW | Substantially Equivalent | Hne 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 |
|---|---|---|---|---|---|---|
| July 30, 2021 | 88403 | Class II | Terminated | Arjo Disposable Repositioning Sling, Model AHD001 | Sling loop straps on device pose a trip hazard. | accessdata.fda.gov |
Compare with other makers
- All makers of Lift, Patient, Non-Ac-Powered
- All makers of Aid, Transfer
- All makers of Device, Transfer, Patient, Manual
- All makers of Sleeve, Limb, Compressible
- All makers of Bed, Flotation Therapy, Powered
Updated October 11, 1996. 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.