HELAVO CORPORATION

FDA Device Registration & Listing · Miami, FL, US · Registration 3022159079

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
3022159079
FEI Number
3022159079
Entity Name
HELAVO CORPORATION
City/State/Country
Miami, FL, US
Establishment Address
444 Brickell Avenue Suite 700, Miami, FL 33131, US
Establishment Type(s)
Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Helavo Corporation (Owner Number: 10084712)
Owner / Operator Contact Address
444 Brickell Avenue Suite 700, Miami, FL 33131, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K242471
PMA Number
N/A

All Registered Proprietary Names

helavo Electric Wheelchair Dual Battery H2010 helavo Electric Wheelchair Magnesium H2320

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2024-02-13
ITI Wheelchair, Powered Physical Medicine Class 2 890.3860 2025-12-19
ITI Wheelchair, Powered Physical Medicine Class 2 890.3860 2025-12-19

Official Correspondent

Nick Hoppner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Helavo Corporation
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
K853594 Vessa , Ltd. VESSA FLIVVA 1985-09-24
K142783 Heartway Medical Products Co., Ltd. HEARTWAY Electrically Powered Wheelchair P27 2015-06-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022159079. Last updated year: 2026. Please use registration number 3022159079 when referencing this establishment in official correspondence.
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