Data / Medical devices / United States / Agiliti Health - Hays
Agiliti Health - Hays: FDA-registered device maker in Hays, KS, United States, 2 510(k) clearances
Agiliti Health - Hays is registered with the FDA (registration 1931307) in Hays, KS, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 7, 1996. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1931307
- Address
- 500 Commerce Pkwy, Hays, KS, United States, 67601
- Owner or operator
- RAYE'S, Inc dba Sizewise Manufacturing a wholly owned subsid (1931307)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 12, 2001
- Registered through
- 2026
- Brand names listed
- Adapt Air, Adapt Air Pro, Adapt Convertible, Adapt Crib , Adapt Pedi , Alliance, Alternate, Alternating Pressure Air Flotation Overlay Systems and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Hygiene | ILS | 1 | Manufacturer | accessdata.fda.gov |
| Bed, Ac-Powered Adjustable Hospital | FNL | 2 | Manufacturer | accessdata.fda.gov |
| Bed, Flotation Therapy, Powered | IOQ | 2 | Manufacturer | accessdata.fda.gov |
| Bed, Patient Rotation, Powered | IKZ | 2 | Manufacturer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Manufacturer | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Specification developer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | 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 |
|---|---|---|---|---|---|---|
| May 7, 1996 | K961514 | BCW ADVANTAGE WHEELCHAIR | IOR | Substantially Equivalent | Wheelchairs of Kansas | accessdata.fda.gov |
| August 2, 1988 | K883034 | WHEELCHAIR BCW 6000 | IOR | Substantially Equivalent | O'Tec Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 25, 2024 | 93887 | Class II | Ongoing | SW Bari Lift & Transfer, Model Number 38060000 | Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a | accessdata.fda.gov |
| November 14, 2005 | 35061 | Not yet classified | Terminated | Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7'' to a high position of 30''. The beds are distributed by SIZEWise Rentals, Ellis, KS. | The bed may drop due to a malfunction of the actuator exceeding its stop. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Mechanical
- All makers of Bed, Flotation Therapy, Powered
- All makers of Bed, Patient Rotation, Powered
- All makers of Bed, Ac-Powered Adjustable Hospital
- All makers of Mattress, Air Flotation, Alternating Pressure
- All makers of Walker, Mechanical
Updated April 18, 2024. 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.