Inbody

FDA 510(k) K110689 · Biospace Corporation Limited

Substantially Equivalent

510(k) numberK110689

Submission

Device name
Inbody
Applicant
Biospace Corporation Limited
Naples, FL, US
Received
March 15, 2011
Decision date
August 19, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNW – Analyzer, Body Composition
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

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K130856Bia / Vitality AnalyzerMNW · Traditional Ipgdx, LLC11/25/2013SE
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More from Guangdong Transtek Medical Electronics Co., Ltd.

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K141483Biospace Body Composition AnalyzerMNW · Traditional 09/23/2014SE
K130777InbodyMNW · Traditional 11/25/2013SE
K131064BiospaceDXN · Traditional 09/04/2013SE
K123228Inbody 770, Inbody 570, Inbody S10, Inbody H20/INBODY H20(B)MNW · Traditional 03/08/2013SE
K092786Inbody, Models: 270, R20, R20BMNW · Traditional 03/10/2010SE
K062603Biospace Body Composition Analyzers, Model Inbody 230MNW · Traditional 02/15/2007SE
K052646Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20MNW · Special 12/16/2005SE
K042528Inbody, Model 3.0MNW · Traditional 01/11/2005SE
K023478Inbody AP1 Body Composition AnalyzerMNW · Traditional 05/13/2003SE

Questions and answers

When was Inbody cleared by the FDA?

Inbody (K110689) received a 510(k) decision of Substantially Equivalent on August 19, 2011, 157 days after the submission was received.

What is the product code of K110689?

The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.