FDA Registration
Active
🇺🇸 United States
BIONESS MEDICAL, INC.
Reg #: 3036471706
·
FEI: 3036471706
·
Expires 2026
Products
8
Proprietary Names
10
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- BIONESS MEDICAL, INC.
- Registration Number
- 3036471706
- FEI Number
- 3036471706
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 25103 Rye Cyn Loop
- City
- Valencia
- State
- CA
- ZIP
- 91355
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN200050
Owner / Operator
- Firm Name
- Bioness Medical, Inc.
- Operator Number
- 10092201
- Address
- 25103 Rye Cyn Loop
- City
- Valencia
- State
- CA
- Postal Code
- 91355
- Country
- US
- Correspondent
- Christopher Swanson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrical Tongue Stimulator To Treat Motor Deficits | QCF | Class 2 | Neurology | No | 2026-04-13 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2024-12-12 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2024-12-12 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2025-02-28 |
| System, Isokinetic Testing And Evaluation | IKK | Class 2 | Physical Medicine | No | 2024-12-17 |
| Interactive Rehabilitation Exercise Device, Prescription Use | QKC | Class 2 | Physical Medicine | No | 2025-11-14 |
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2024-12-17 |
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 2024-12-17 |
Proprietary Names
PoNS
L100 Go System
L300 Go System
Vector Base
H200 Wireless System
BITS
BITS Functional Reality
Vector Elite System
L360 Thigh System
BITS Balance
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device