FASHIONABLE, INC.

FDA Device Registration & Listing · Largo, FL, US · Registration 3014647250

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014647250
FEI Number
3014647250
Entity Name
FASHIONABLE, INC.
City/State/Country
Largo, FL, US
Establishment Address
12399 S. Belcher Rd, Suite 160, Largo, FL 33773, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Fashionable, Inc. (Owner Number: 10058021)
Owner / Operator Contact Address
12399 S. Belcher Rd, Suite 160, Largo, FL 33773, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K132588
PMA Number
N/A

All Registered Proprietary Names

Royal Canes TENSUNITS OMEGA TENSUNITS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IPS Cane Physical Medicine Class 1 890.3075 2018-06-26
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2020-10-05
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2020-10-05
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2020-10-05

Official Correspondent

Tina Wagner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fashionable, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221200 Xbody Hungary Kft. XBody Go USA, XBody Pro USA 2023-01-31
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014647250. Last updated year: 2026. Please use registration number 3014647250 when referencing this establishment in official correspondence.
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