Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042268484

FEI Number

3042268484

Entity Name

PRAYWISE TECHNOLOGY (DONGGUAN) CO., LTD

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

Room 601,Building 10,No. 180, Maozhu Mountain Road, Changping Town, Dongguan City Guangdong 523000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Praywise Technology (Dongguan) Co., Ltd (Owner Number: 10094303)

Owner / Operator Contact Address

Room 601,Building 10,No. 180, Maozhu Mountain Road, Changping Town, Dongguan City, CN-GD 523000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190347

PMA Number

N/A

All Registered Proprietary Names

HIVOX OTC Electrical Stimulator 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator, EM59-1; HIVOX OTC Electrical Stimulator, EM59-2 stimulator, muscle, powered, for muscle conditioning - 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator EM59-2 Beurer; EM49 TENS/EMS Unit 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator, EM59-1; HIVOX OTC Electrical Stimulator, EM59-2 stimulator, nerve, transcutaneous, over-the-counter - 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator, EM59-2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-11-21
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-11-21
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2025-11-21
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-11-21
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-11-21
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-11-21
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-11-21
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-11-21
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2025-11-21
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-11-21
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-11-21

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Praywise Technology (Dongguan) Co., 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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042268484. Last updated year: 2026. Please use registration number 3042268484 when referencing this establishment in official correspondence.