BIOSPACE INC.

FDA Device Registration & Listing · Cerritos, CA, US · Registration 3003193933

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003193933
FEI Number
3003193933
Entity Name
BIOSPACE INC.
City/State/Country
Cerritos, CA, US
Establishment Address
13850 CERRITOS CORPORATE DR STE C, Cerritos, CA 90703, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
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
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

InBody370 InBody 720 InBody 520 InBody120 InBody120R InBody370S FRA510S Scale Disposable Cuff Barrier Scale BPBIO320n BPBIO320 BPBIO680KV BPBIO 320 S BPBIO780KV BPBIO 320 SN BPBIO 330 S BPBIO 330 SN BPBIO 750 IB-LS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNW Analyzer, Body Composition Cardiovascular Class 2 870.2770 2013-11-27
GWW Ataxiagraph Neurology Class 1 882.1030 2021-03-13
KHX Platform, Force-Measuring Physical Medicine Class 1 890.1575 2020-06-10
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2021-04-14
FRW Scale, Patient General Hospital Class 1 880.2720 2010-11-08
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-09-11
IKK System, Isokinetic Testing And Evaluation Physical Medicine Class 2 890.1925 2020-07-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3022764531 InBody Factory #2, Cheonan-si Chungnam, KR
3003074886 InBody Co, Ltd. Cheonan-si Chungnam, KR

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003193933. Last updated year: 2026. Please use registration number 3003193933 when referencing this establishment in official correspondence.
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