Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025350087

FEI Number

3025350087

Entity Name

LENYO WORLD LTD

City/State/Country

Budapest, HU

Establishment Address

Rakoczi Utca 79, Building B, Budapest 1188, HU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LENYO WORLD LTD (Owner Number: 10086719)

Owner / Operator Contact Address

Rakoczi Utca 79, Building B, Budapest, HU-PE 1188, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lenyo Ultra Wellness Mobile Lenyo Mobile Lady Lenyo Fractal Meridian Lenyo Sleep Lenyo Fitness Lenyo Newborn Lenyo Child Lenyo Lux Pro Lenyo Mobile Port Nesta Sleep Nesta Metabalance Lenyo Horse Mobile Lenyo Fractal Lenyo SanoCenter Lenyo Mobile Lenyo Woman Lenyo Yoga Nesta Mobile Lenyo Fitness Mobile Lenyo Office Lenyo Mobile Pet Nesta Child Lenyo Meridian Lenyo Sport Lenyo Lux Plus Nesta Programmable Lenyo Harmony Lenyo Space Harmoniser Lenyo Horse Lenyo CellCom Nesta Bioreg

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-12-05
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2022-12-05

Official Correspondent

Eleonora Bakos

US Agent Details

Kym Heisler Email: kymheisler@gmail.com Phone: (619) 7427422

Related Public Records

Same Entity

LENYO WORLD LTD

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
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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3009079475	Aerotel Ltd.	Holon Central, IL
3027692296	CENTROPIX GLOBAL AG	Ruggell, LI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025350087. Last updated year: 2026. Please use registration number 3025350087 when referencing this establishment in official correspondence.