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510(k) K014009

TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE by Tanita Corp. of America — Product Code MNW

K014009 is an FDA 510(k) premarket notification submitted by Tanita Corp. of America for the device "TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE". The FDA issued a decision of Substantially Equivalent on June 24, 2002. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Tanita Corp. of America has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2002
Date Received
December 5, 2001
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 Tanita Corp. of America

  • K040778 — TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) (December 23, 2004)
  • K040978 — TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE (July 22, 2004)
  • K033157 — TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418 (April 8, 2004)
  • K930599 — BODY FAT ANALYZER MODEL TBF-105 (November 1, 1994)
  • K932572 — DIGITAL BABY SCALE MODEL BLB-12 (November 16, 1993)

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