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510(k) K102191

TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER by Zhongshan Transtek Electronics Co., Ltd. — Product Code MNW

K102191 is an FDA 510(k) premarket notification submitted by Zhongshan Transtek Electronics Co., Ltd. for the device "TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER". The FDA issued a decision of Substantially Equivalent on May 2, 2011. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Zhongshan Transtek Electronics Co., Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2011
Date Received
August 3, 2010
Clearance Type
Abbreviated
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 Zhongshan Transtek Electronics Co., Ltd.

  • K123780 — TRANSTEK BLOOD PRESSURE MONITOR (March 1, 2013)
  • K123781 — TRANSTEK GLASS BODY FAT ANALYZER (January 9, 2013)
  • K123669 — TRANSTEK WRIST BLOOD PRESSURE MONITOR (December 21, 2012)
  • K122482 — TRANSTEK WRIST BLOOD PRESSURE MONITOR (October 22, 2012)
  • K121971 — WITHINGS, SMART BODY SCALE (September 27, 2012)
  • K120058 — TRANSTEK BLOOD PRESSURE MONITOR (January 31, 2012)
  • K112932 — TRANSTEK (November 1, 2011)
  • K101681 — TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 (May 27, 2011)

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