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InBody

FDA UDI

Class II (US FDA UDI)

by InBody Co., Ltd.

Identity

Trade Name
InBody FDA UDI
Generic Name
Bioelectrical body composition analyser FDA UDI
Device Name
Body Composition Analyzer FDA UDI
Model / Reference
InBody370 FDA UDI
Description
Body Composition Analyzer FDA UDI

Identifiers

Primary DI / UDI-DI
08809209590501 FDA UDI
510(k) Number
K130777 FDA UDI
FDA Product Code
MNW FDA UDI
GMDN Term
Bioelectrical body composition analyser FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2770 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bioelectrical body composition analyser

InBody by InBody Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bioelectrical body composition analyser.

Cleared under the same submission

K130777 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
InBody Co., Ltd.

Sources (1)

  • FDA UDI 80bab3ce-2c11-4a8c-90a4-bb07727f89a3 36 fields · synced May 31, 2026