FDA Registration
Active
🇺🇸 United States
FRONTIER THERAPEUTICS INC.
Reg #: 3015423385
·
FEI: 3015423385
·
Expires 2026
Products
6
Proprietary Names
26
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- FRONTIER THERAPEUTICS INC.
- Registration Number
- 3015423385
- FEI Number
- 3015423385
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 505 Ellicott St, Suite A5
- City
- Buffalo
- State
- NY
- ZIP
- 14203
- Country
- US
Owner / Operator
- Firm Name
- Frontier Therapeutics Inc.
- Operator Number
- 10059719
- Address
- 505 Ellicott St, Suite A5
- City
- Buffalo
- State
- NY
- Postal Code
- 14203
- Country
- US
- Correspondent
- Joseph Bockus
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2019-05-29 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2019-05-29 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2019-05-29 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2021-11-11 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2019-05-29 |
| Bed, Patient Rotation, Powered | IKZ | Class 2 | Physical Medicine | No | 2019-05-29 |
Proprietary Names
Repose Babynest
Repose Babytherm
ReposeTrolley Mattress Overlay
Repose Pediatric Mattress Overlay
Repose Double Mattress Overlay
Repose Mattress Overlay
Repose Contur Overlay
Enora Air Sleeper
Enora Air Contur
Dermisplus Prevent
Repose Foot Protector Plus
Repose Foot Protector
Repose Wedge
Repose Sole Protector
Repose Flex
Repose Mattress Cover
Enora Air Cushion Cover
Repose Cushion Cover
Enora Air Sleeper Cover
Repose Care-Sit
Repose Cushion
Enora Air Seat
Enora Air Cushion
Repose Companion
Repose Trolley Companion
Toto Automated Lateral Turning System
Establishment Types
Complaint File Establishment per 21 CFR 820.198