Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010190204

FEI Number

3010190204

Entity Name

MedHealth Medical Limited

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

701/101, BLDG 24, Block B, Yuanshan Zone, Shangcun, Gongming, Shenzhen Guangdong 518106, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Medhealth Medical Limited (Owner Number: 10042861)

Owner / Operator Contact Address

701/101, BLDG 24, Block B, Yuanshan Zone, Shangcun, Gongming, Shenzhen, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Portable DVT Pump VasoGrad Garment MHH800/MHH800SQ DVT Pump CIRCASSIST DVT PUMP VasoPress Pump VasoPress Garment ALP 1SM Calf Garment; ALP 2 Calf Garment; ALP 2XL Garment; ALP 2XXL Calf Garment; ALP 3 Thigh Garment; ALP 3SM Thigh Garment; ALP 4 Thigh Garment; ALP 4XL Thigh Garment; ALP 1 Calf Garment; ALP 1A Calf Garment VasoGrad Garment VasoPress Garment VasoPress Pump

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2020-10-23
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2016-12-18
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2020-08-15
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-01-07
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2016-12-18
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-05-05
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-02-13
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-10-17
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2019-03-14
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-01-07
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-01-07

Official Correspondent

Billy Yu

US Agent Details

Leonard Nass Business: ORLENMAR HEALTHCARE LLC Email: leonardnass@gmail.com Phone: (732) 7025120

Related Public Records

Same Entity

Medhealth Medical Limited

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
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

Similar Registrations

Registration Number	Establishment Name	Location
3033981998	KOYA MEDICAL, INC.	Dallas, TX, US
3020703724	Therma Bright Inc.	Toronto Ontario, CA
3014491159	AIROS MEDICAL INC	Audubon, PA, US
3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3009155917	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010190204. Last updated year: 2026. Please use registration number 3010190204 when referencing this establishment in official correspondence.