Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1044692

FEI Number

1044692

Entity Name

Magnatone Hearing Aid Corp. dba Persona Medical

City/State/Country

Casselberry, FL, US

Establishment Address

170 N. Cypress Way, Casselberry, FL 32707, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Magnatone Hearing Aid Corp. dba Persona Medical (Owner Number: 10023549)

Owner / Operator Contact Address

170 N. Cypress Way, Casselberry, FL 32707, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BT1S RX8 RX9 RXS RX4 RXi CENTURY RB 300 CENTURY RB 200 CENTURY RB 100 Fluency Master Sombra 8R RX Ear Open Fit Sombra 4P Evok 920r Sombra 8P Sombra 4R Sombra 8S Sombra 4S Evok 927r Ole' 2125 Claret 100 Claret 360 Claret 335 Claret 320 Claret 330 Claret 300 Claret 315 Claret 310 Ole' 2 Claret 325 Claret 425 Ole 2127 Claret 365 Claret 400 Ole 2128r GEN5 Claret 450 ICOT Alpha PDS1 Claret 334 Olé 2127r Olé 2128 Olé 2117 Olé 2137 Evok 1600 OLM Claret 300 Monet 500 Emet OL-C Perfect Ear Claret 100 Monet 500 Power Monet 300 Power Magnatone Monet 300 Evok Claret 100 Power Monet Claret 300 Power TruVoice Emet OM Ole' 2100 OL-M Evok 500 Claret CS Ole'-HD OL-I Olé OL-F Olé EK-H Evok EK-D Evok EK-I Evok EK-F Evok EN-D Evok 900 IIC EK-FP Evok EK-C Evok EN-CP Evok EK-CP Evok EK-HP Evok OL-FP Olé EK-D Evok 2100 IIC OL-HP Olé OL-IP Olé OL-H Olé EVOK-900 EVOK-700 Evok 540 Claret CO Monet 320 Monet 300 Monet 530 Monet 4D+ Monet 330 Monet 4D Monet 537 Monet 325 Opa 400 RX7 Sombra VS RX8 Sombra XR Sombra VR RX9 Sombra XS Evok Ri

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2023-08-21
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2007-11-30
KTH	Device, Anti-Stammering	Ear, Nose, Throat	Class 1	874.5840	2009-08-28
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2007-11-30
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2007-11-30
LRB	Face Plate Hearing Aid	Ear, Nose, Throat	Class 1	874.3300	2007-11-30
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2007-11-30
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2017-07-06

Official Correspondent

Don Campbell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Magnatone Hearing Aid Corp. dba Persona Medical

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
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

Similar Registrations

Registration Number	Establishment Name	Location
3016157573	ZHUHAI ZOROSY TECHNOLOGY CO., LTD.	Zhuhai Guangdong, CN
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3027300374	SHENZHEN AKAUDIO CO., LIMITED	Shenzhen Guangdong, CN
3033659461	SHENZHEN SOUNDS GOOD TECHNOLOGIES CO., LTD	Shenzhen Guangdong, CN
3008460009	Shenzhen Zhongde Audio-Technical Co., Ltd.	Shenzhen City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1044692. Last updated year: 2026. Please use registration number 1044692 when referencing this establishment in official correspondence.