FDA Registration
Active
🇺🇸 United States
Agiliti Health - Hays
Reg #: 1931307
·
FEI: 1931307
·
Expires 2026
Products
8
Proprietary Names
45
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- Agiliti Health - Hays
- Registration Number
- 1931307
- FEI Number
- 1931307
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 500 Commerce Pkwy
- City
- Hays
- State
- KS
- ZIP
- 67601
- Country
- US
Regulatory Submissions
- 510(k) Number
- K961514
Owner / Operator
- Firm Name
- RAYE'S, inc dba Sizewise Manufacturing
- Operator Number
- 1931307
- Address
- 500 Commerce Pkwy
- City
- Hays
- State
- KS
- Postal Code
- 67601
- Country
- US
- Correspondent
- Heidi - Drafall
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2004-02-04 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2004-07-01 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2008-11-14 |
| Bed, Flotation Therapy, Powered | IOQ | Class 2 | Physical Medicine | No | 2022-12-06 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2005-08-24 |
| Bed, Patient Rotation, Powered | IKZ | Class 2 | Physical Medicine | No | 2022-12-06 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2001-07-12 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2001-08-01 |
Proprietary Names
Alliance
Sizewise Evolution Bed
Essentia
Sizewise Advantage Bed
Bari-Rehab Bed
Mighty Rest Rehab Bed
Sizewise Behavioral Health Bed
Sizewise Low Bed
Alternating Pressure Air Flotation Systems
NPT3
Adapt Convertible
Adapt Air Pro
Alternate
Platinum 6000
Alternating Pressure Air Flotation Overlay Systems
NPT4
Dabir Surgical System
Mighty Air
Adapt Air
Capillaire OR
Dabir Patient Care Plus
Capillaire OR Lithotomy
Capillaire ST
Capillaire SS
Capillaire OR Pedi
Capillaire Crib
BCW Advantage Wheelchair
Powered Flotation Therapy Bed
Immerse
Pulsate
Adapt Pedi
Adapt Crib
Sizewise Shuttle B Series
Sizewise Shuttle A Series
Sizewise Shuttle A Series Advanced
Sizewise Shuttle B Series Advanced
Rotate
Bed, Patient Rotation, Powered
Big Turn
BCW 600 Manual Wheelchair
WOK750 - WALKER
BARI-COMMODE CHAIR
TUB TRANSFER BENCH
FOLDING SHOWER CHAIR
SHOWER COMMODE CHAIR
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility