INBODY BWA, INC.

FDA Device Registration & Listing · Trooper, PA, US · Registration 3027717071

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
3027717071
FEI Number
3027717071
Entity Name
INBODY BWA, INC.
City/State/Country
Trooper, PA, US
Establishment Address
2550 Eisenhower Avenue, Suite C209, Trooper, PA 19403, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
InBody BWA, Inc. (Owner Number: 10088864)
Owner / Operator Contact Address
2550 Eisenhower Avenue, Suite C209, Trooper, PA 19403, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K141483
PMA Number
N/A

All Registered Proprietary Names

BPBIO 320 S; BPBIO 320 SN; BPBIO 330 S; BPBIO 330 SN; BPBIO 750; BPBIO320; BPBIO320n; BPBIO680KV; BPBIO780KV Scale Scale BWA2; BWA2S; InBody270S; InBody380; InBody580; InBody770S; InBody970; InBody970S; InBodyBAND2; Yscope IB-LS InBody 120; InBody 120R; InBody 370; InBody 370S; InBody 520; InBody 720 BWA 2; BWA ON; InBody 230; InBody 270 InBody 380; InBody 470; InBody 570; InBody 580 InBody 770; InBody 970; InBody H20(B); InBody M20; InBody S10 InBody230; InBody270; Inbody470; InBody570; InBody770

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-03-19
FRW Scale, Patient General Hospital Class 1 880.2720 2025-03-19
KHX Platform, Force-Measuring Physical Medicine Class 1 890.1575 2025-03-19
PUH Analyzer, Body Composition, Exempt Cardiovascular Class 2 870.2770 2025-03-19
IKK System, Isokinetic Testing And Evaluation Physical Medicine Class 2 890.1925 2025-03-19
MNW Analyzer, Body Composition Cardiovascular Class 2 870.2770 2025-03-19
MNW Analyzer, Body Composition Cardiovascular Class 2 870.2770 2025-03-20

Official Correspondent

Joongwon Lee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

InBody BWA, 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
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027717071. Last updated year: 2026. Please use registration number 3027717071 when referencing this establishment in official correspondence.
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