Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022764531

FEI Number

3022764531

Entity Name

InBody Factory #2,

City/State/Country

Cheonan-si Chungnam, KR

Establishment Address

330, Yeongok-gil, Ipjang-myueon, Seoubuk-gu,, Cheonan-si Chungnam 31026, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

InBody Co. Ltd. (Owner Number: 9041413)

Owner / Operator Contact Address

15, Heugam-gil, Ipjang-myueon, Seoubuk-gu,, Cheonan-si,, KR-44 31025, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Scale BP170B BPBIO250 BP160B BP170 BP160 BPBIO220T BPBIO210T BPBIO210 BPBIO220 Scale

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHX	Platform, Force-Measuring	Physical Medicine	Class 1	890.1575	2020-06-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-12-04
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-01-06
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2021-01-06
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2010-11-08

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

InBody Co. Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003193933	BIOSPACE INC.	Cerritos, CA, US
3003074886	InBody Co, Ltd.	Cheonan-si Chungnam, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

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.

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3013687630	MELOQ AB	Stockholm, SE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022764531. Last updated year: 2026. Please use registration number 3022764531 when referencing this establishment in official correspondence.