Atlas FDA

BODY COMPOSITION ANALYZER

FDA 510(k) clearance K140045 · decided 2015-02-18

Clearance details

K-number
K140045
Device name
BODY COMPOSITION ANALYZER
Applicant
Jawon Medical Co., Ltd.
Decision
Substantially Equivalent
Date received
2014-01-08
Decision date
2015-02-18
Days to decision
406 days
Clearance type
Traditional
Product code
MNW
Device class
2
Regulation number
870.2770
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Kyungsan-City, Kyungsan-Bukdo, KR
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Multi-parameter detector (K231116)Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.2024-06-15
BIOSPACE BODY COMPOSITION ANALYZER (K141483)Biospace Corporation Limited2014-09-23
ARIA WIFI SMART SCALE (K133872)Fitbit, Inc.2014-06-02
BODY FAT ANALYZER AND SCALE (K140594)Conmo Electronic Company Limited2014-05-30
INBODY (K130777)Biospace Corporation Limited2013-11-25
BIA / VITALITY ANALYZER (K130856)Ipgdx, LLC2013-11-25
PRECISION ONE LIFECARE; DETECTO; DETECTO (K130952)Precision One Lifecare, Ltd.2013-09-26
TRANSTEK GLASS BODY FAT ANALYZER (K131394)Guangdong Transtek Medical Electronics Co., Ltd.2013-09-18
TRANSTEK BODY FAT ANALYZER (K130311)Guangdong Transtek Medical Electronics Co., Ltd.2013-05-30
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 (K122388)Seca GmbH & Co. KG2013-05-02
INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) (K123228)Biospace Corporation Limited2013-03-08
TRANSTEK GLASS BODY FAT ANALYZER (K123781)Zhongshan Transtek Electronics Co., Ltd.2013-01-09

Recalls involving this device

No recalls on record reference this clearance.