FDA Registration
Active
🇺🇸 United States
Compex Wireless USA
Reg #: 3017264244
·
FEI: 3017264244
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- DJO, LLC
- Registration Number
- 3017264244
- FEI Number
- 3017264244
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5919 Sea Otter Place, Suite 200
- City
- Carlsbad
- State
- CA
- ZIP
- 92010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170903
Owner / Operator
- Firm Name
- DJO, LLC
- Operator Number
- 9015378
- Address
- 5919 Sea Otter Place, Suite 200
- City
- Carlsbad
- State
- CA
- Postal Code
- 92010
- Country
- US
- Correspondent
- Dave Hunter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2017-11-07 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2017-11-07 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2017-11-07 |
Proprietary Names
Compex Wireless USA
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198