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FDA 510(k)

BODY COMPOSITION ANALYZER, MODEL: IOI 353

K-Number: K092431 · 2009-10-08

ApplicantJawon Medical Co., Ltd.
Decision Date2009-10-08
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BODY COMPOSITION ANALYZER, MODEL: IOI 353 is the device name listed in this FDA 510(k) record. The listed applicant is Jawon Medical Co., Ltd.. It received FDA 510(k) clearance on 2009-10-08 under 510(k) number K092431. The device is classified under product code MNW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODY COMPOSITION ANALYZER, MODEL: IOI 353?

BODY COMPOSITION ANALYZER, MODEL: IOI 353 is a medical device that received FDA 510(k) clearance on 2009-10-08. The listed applicant is Jawon Medical Co., Ltd.. The 510(k) number is K092431.

When did BODY COMPOSITION ANALYZER, MODEL: IOI 353 receive FDA 510(k) clearance?

BODY COMPOSITION ANALYZER, MODEL: IOI 353 received FDA 510(k) clearance on 2009-10-08, under 510(k) number K092431.

Who is the listed applicant for BODY COMPOSITION ANALYZER, MODEL: IOI 353?

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

What is the FDA product code for BODY COMPOSITION ANALYZER, MODEL: IOI 353?

The FDA product code for BODY COMPOSITION ANALYZER, MODEL: IOI 353 is MNW.

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Other records listing Jawon Medical 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.

K092432AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)K072325BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205K071884BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900K062462NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/LK053556BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5K013876INFRARED EAR THERMOMETER, MODEL DX-707

View all 11 devices →

Related Devices (Code: MNW)

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.

K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.K130856BIA / VITALITY ANALYZERIpgdx, LLCK130777INBODYBiospace Corporation LimitedK130952PRECISION ONE LIFECARE; DETECTO; DETECTOPrecision One Lifecare, Ltd.K131394TRANSTEK GLASS BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.K130311TRANSTEK BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.

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.

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