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510(k) K130856

BIA / VITALITY ANALYZER by Ipgdx, LLC — Product Code MNW

K130856 is an FDA 510(k) premarket notification submitted by Ipgdx, LLC for the device "BIA / VITALITY ANALYZER". The FDA issued a decision of Substantially Equivalent on November 25, 2013. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2013
Date Received
March 28, 2013
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 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)
  • 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)
  • K122388 — SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 (May 2, 2013)

FDA data resources