Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017866822

FEI Number

3015460945

Entity Name

NEUROLOGICAL FITNESS EQUIPMENT AND EDUCATION LLC

City/State/Country

Austin, TX, US

Establishment Address

2499 South Capital of Texas Highway, A-100, Austin, TX 78746, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Neurological Fitness Equipment and Education LLC (Owner Number: 10079975)

Owner / Operator Contact Address

2499 S Capital of Texas Hwy, A-100, Austin, TX 78746, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K993229

PMA Number

N/A

All Registered Proprietary Names

Neubie

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2021-01-06
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2021-01-06
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-01-06

Official Correspondent

Garrett Salpeter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neurological Fitness Equipment and Education LLC

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
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03

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3010805941	BIO PROTECH YANTAI INC	Yantai Shandong, CN
3004558433	BIOWAVE CORPORATION	NORWALK, CT, US
3014315574	BRH MEDICAL LTD	Jerusalem, IL
9615033	FUJI DYNAMICS LIMITED	Dongguan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017866822. Last updated year: 2026. Please use registration number 3017866822 when referencing this establishment in official correspondence.