Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

InBody

K-Number: K200560 · 2021-01-06

ApplicantInbody Co., Ltd.
Decision Date2021-01-06
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

InBody is the device name listed in this FDA 510(k) record. The listed applicant is Inbody Co., Ltd.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K200560. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InBody?

InBody is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Inbody Co., Ltd.. The 510(k) number is K200560.

When did InBody receive FDA 510(k) clearance?

InBody received FDA 510(k) clearance on 2021-01-06, under 510(k) number K200560.

Who is the listed applicant for InBody?

The FDA 510(k) record lists Inbody Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InBody?

The FDA product code for InBody is DXN.

Other records listing Inbody Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231174BPBIO750K221764InBody Blood pressure monitor, Model BPBIO480KVK200442InBody

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑