Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616164

FEI Number

3001058906

Entity Name

SELVAS Healthcare, Inc.

City/State/Country

Yuseong-gu Daejeon, KR

Establishment Address

155, Sinseong-ro, Yuseong-gu Daejeon 34109, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SELVAS Healthcare, Inc. (Owner Number: 9034171)

Owner / Operator Contact Address

155, Sinseong-ro, Yuseong-gu, Daejeon, Daejeon, KR-30 34109, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092432

PMA Number

N/A

All Registered Proprietary Names

ACCUNIQ BC360 ACCUNIQ BC720 ACCUNIQ BC380 EV360 ACCUNIQ BC390 ACCUNIQ BC730 ACCUNIQ BC310 ACCUNIQ BC300 ACCUNIQ BP210 ACCUNIQ BP250

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2018-08-16
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2015-05-27
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2009-10-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2009-10-11

Official Correspondent

Kiwon Kim

US Agent Details

Randy Ahn Business: HIMS, Inc. Email: randy@selvashc.com Phone: (512) 9609889

Related Public Records

Same Entity

SELVAS Healthcare, Inc.

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
K994242	Bodystat , Ltd.	BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT	2000-03-15
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

Registration Number	Establishment Name	Location
3044921217	SHANGHAI YOUJOY HEALTH TECHNOLOGY CO., LTD.	shanghai, CN
3006026335	Shenzhen Shine Industrial Co., Ltd.	Shenzhen Guangdong, CN
3012094189	BIOTEKNA SRL	Marcon Veneto, IT
3007695022	Guangdong Winburg Technology Co.,Ltd	ZHONGSHAN Guangdong, CN
3006624940	SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616164. Last updated year: 2026. Please use registration number 9616164 when referencing this establishment in official correspondence.