InBody

GUDID 08809209590686

The InBody blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm.

InBody Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 08809209590686
• NIH Device Record Key: 7f2ef112-ffec-4a77-9d8a-4760145d7e02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InBody
• Version Model Number: BPBIO320S
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809209590686 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131064

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-10-08

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
• 08809209591980: This is a Handheld Dynamometer