FDA Registration
Active
🇺🇸 United States
TENSUNITS
Reg #: 3014647250
·
FEI: 3014647250
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- FASHIONABLE, INC.
- Registration Number
- 3014647250
- FEI Number
- 3014647250
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12399 S. Belcher Rd, Suite 160
- City
- Largo
- State
- FL
- ZIP
- 33773
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132588
Owner / Operator
- Firm Name
- Fashionable, Inc.
- Operator Number
- 10058021
- Address
- 12399 S. Belcher Rd, Suite 160
- City
- Largo
- State
- FL
- Postal Code
- 33773
- Country
- US
- Correspondent
- Tina Wagner
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2020-10-05 |
Proprietary Names
TENSUNITS
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198