FDA Registration
Active
🇺🇸 United States
BTE TECHNOLOGIES
Reg #: 1119903
·
FEI: 1119903
·
Expires 2026
Products
5
Proprietary Names
12
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- BTE TECHNOLOGIES
- Registration Number
- 1119903
- FEI Number
- 1119903
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7455-L NEW RIDGE RD.
- City
- HANOVER
- State
- MD
- ZIP
- 21076
- Country
- US
Regulatory Submissions
- 510(k) Number
- K800007
Owner / Operator
- Firm Name
- BTE TECHNOLOGIES
- Operator Number
- 1119903
- Address
- 7455-L NEW RIDGE RD.
- City
- Hanover
- State
- MD
- Postal Code
- 21076
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2006-05-09 |
| System, Isokinetic Testing And Evaluation | IKK | Class 2 | Physical Medicine | No | 2006-05-09 |
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 2006-05-09 |
| Platform, Force-Measuring | KHX | Class 1 | Physical Medicine | No | 2024-02-09 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 1992-08-31 |
Proprietary Names
Simulator II SIM II 5
Simulator II SIM II 03
Evaluator
Prism
Eccentron
EvalTech
EVJ
MCU Multi-Cervical Unit
Provider Test Kit (PTK)
PrimusRS
Alfa
Capri
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device