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510(k) K053556

BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 by Jawon Medical Co., Ltd. — Product Code MNW

K053556 is an FDA 510(k) premarket notification submitted by Jawon Medical Co., Ltd. for the device "BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5". The FDA issued a decision of Substantially Equivalent on August 31, 2006. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Jawon Medical Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2006
Date Received
December 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Body Composition
Device Class
Class II
Regulation Number
870.2770
Review Panel
GU
Submission Type

Other clearances by Jawon Medical Co., Ltd.

  • K140762 — AUTOMATIC BLOOD PRESSURE MONITOR (July 2, 2015)
  • K140045 — BODY COMPOSITION ANALYZER (February 18, 2015)
  • K092432 — AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) (October 9, 2009)
  • K092431 — BODY COMPOSITION ANALYZER, MODEL: IOI 353 (October 8, 2009)
  • K072325 — BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 (November 30, 2007)
  • K071884 — BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, (August 9, 2007)
  • K062462 — NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L (September 29, 2006)
  • K013876 — INFRARED EAR THERMOMETER, MODEL DX-707 (March 4, 2002)
  • K002722 — DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 (September 11, 2000)
  • K000675 — MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502 (March 14, 2000)

Other clearances for product code MNW

  • K231116 — Multi-parameter detector (June 15, 2024)
  • K140045 — BODY COMPOSITION ANALYZER (February 18, 2015)
  • K141483 — BIOSPACE BODY COMPOSITION ANALYZER (September 23, 2014)
  • K133872 — ARIA WIFI SMART SCALE (June 2, 2014)
  • K140594 — BODY FAT ANALYZER AND SCALE (May 30, 2014)
  • K130777 — INBODY (November 25, 2013)
  • K130856 — BIA / VITALITY ANALYZER (November 25, 2013)
  • K130952 — PRECISION ONE LIFECARE; DETECTO; DETECTO (September 26, 2013)
  • K131394 — TRANSTEK GLASS BODY FAT ANALYZER (September 18, 2013)
  • K130311 — TRANSTEK BODY FAT ANALYZER (May 30, 2013)

FDA data resources