Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038912617

FEI Number

3038912617

Entity Name

FASIKL INCORPORATED

City/State/Country

Bloomington, MN, US

Establishment Address

8500 Normandale Lake Blvd Ste 400, Bloomington, MN 55437, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Fasikl Incorporated (Owner Number: 10093772)

Owner / Operator Contact Address

8500 Normandale Lake Blvd, Suite 400, Bloomington, MN 55437, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250096

PMA Number

N/A

All Registered Proprietary Names

Felix NeuroAI Wristband

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QBC	External Upper Limb Tremor Stimulator	Neurology	Class 2	882.5897	2025-07-08

Official Correspondent

Zhen Zhang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fasikl Incorporated

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3043526479	ENCORA, INC	Boston, MA, US
3031696786	HANGZHOU FASIKL TECHNOLOGY CO., LTD	Hangzhou Zhejiang, CN
3011628389	CALA HEALTH, INC.	Foster City, CA, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038912617. Last updated year: 2026. Please use registration number 3038912617 when referencing this establishment in official correspondence.