Data / Medical devices / United States / Fashionable, Inc.
Fashionable, Inc.: FDA-registered device maker in Largo, FL, United States, 3 510(k) clearances
Fashionable, Inc. is registered with the FDA (registration 3014647250) in Largo, FL, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 2, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014647250
- Address
- 12399 S. Belcher Rd Suite 160, Largo, FL, United States, 33773
- Owner or operator
- Fashionable, Inc. (10058021)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 26, 2018
- Registered through
- 2026
- Brand names listed
- Royal Canes, TENSUNITS, TENSUNITS OMEGA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cane | IPS | 1 | Specification developer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 2, 2019 | K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) | NUH | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| November 22, 2013 | K132588 | ADHESIVE ELECTRODES | GXY | Substantially Equivalent | Top-Rank Health Care Equipment Co., Ltd. | accessdata.fda.gov |
| May 10, 2013 | K121719 | SM TENS & PMS | NGX | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Cane
Updated December 2, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.