FDA Registration
Active
🇺🇸 United States
FASHIONABLE, INC.
Reg #: 3014647250
·
FEI: 3014647250
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- FASHIONABLE, INC.
- Registration Number
- 3014647250
- FEI Number
- 3014647250
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12399 S. Belcher Rd, Suite 160
- City
- Largo
- State
- FL
- ZIP
- 33773
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190009
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 |
|---|---|---|---|---|---|
| Cane | IPS | Class 1 | Physical Medicine | No | 2018-06-26 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2020-10-05 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2020-10-05 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2020-10-05 |
Proprietary Names
Royal Canes
TENSUNITS OMEGA
TENSUNITS
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198