InBody

GUDID 08809209590822

The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.

InBody Co., Ltd.

Aneroid manual sphygmomanometer

• Primary Device ID: 08809209590822
• NIH Device Record Key: 4973606d-050a-41fe-8eac-4449eb918e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InBody
• Version Model Number: BPBIO210
• Company DUNS: 688003404
• Company Name: InBody Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 323-932-6503
• Email: info@inbodyusa.com
• Phone: 323-932-6503
• Email: info@inbodyusa.com
• Phone: 323-932-6503
• Email: info@inbodyusa.com
• Phone: 323-932-6503
• Email: info@inbodyusa.com
• Phone: 323-932-6503
• Email: info@inbodyusa.com
• Phone: 323-932-6503
• Email: info@inbodyusa.com
• Phone: 323-932-6503
• Email: info@inbodyusa.com
• Phone: 323-932-6503
• Email: info@inbodyusa.com
• Phone: 323-932-6503
• Email: info@inbodyusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809209590822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200560

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-02
• Device Publish Date: 2022-07-25

On-Brand Devices [InBody]

• 08809209590686: The InBody blood pressure monitor is designed to measure blood pressure (diastolic and systolic)
• 08809209590877: Body composition analyzer which is not intended to diagnose or treat any medical condition.
• 08809209590853: Body composition analyzer which is not intended to diagnose or treat any medical condition.
• 08809209590846: Body composition analyzer which is not intended to diagnose or treat any medical condition.
• 08809209590822: The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for
• 08809209590815: The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for
• 08809209590808: The InBody blood pressure monitor is designed to measure blood pressure (diastolic and systolic)
• 08809209590747: The InBody blood pressure monitor is designed to measure blood pressure (diastolic and systolic)
• 08809209590693: The InBody blood pressure monitor is designed to measure blood pressure (diastolic and systolic)
• 08809209590679: Body composition analyzer which is not intended to diagnose or treat any medical condition.
• 08809209590563: The InBody blood pressure monitor is designed to measure blood pressure (diastolic and systolic)
• 08809209591683: Body Composition Analyzer
• 08809209591676: Body Composition Analyzer
• 08809209591386: Impedance information can be continuously measured in a specified range from two electrodes.
• 08809209591379: Impedance information can be continuously measured in a specified range from two electrodes.
• 08809209591362: Impedance information can be continuously measured in a specified range from two electrodes.
• 08809209590976: Body Composition Analyzer
• 08809209590945: System, Isokinetic Testing And Evaluation
• 08809209590938: Ataxiagraph
• 08809209591911: Body Composition Analyzer, Exempt
• 08809209591904: Body Composition Analyzer, Exempt
• 08809209591898: Body Composition Analyzer, Exempt
• 08809209591881: Body Composition Analyzer, Exempt
• 08809209590969: Body Composition Analyzer