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510(k) K130952

PRECISION ONE LIFECARE; DETECTO; DETECTO by Precision One Lifecare, Ltd. — Product Code MNW

K130952 is an FDA 510(k) premarket notification submitted by Precision One Lifecare, Ltd. for the device "PRECISION ONE LIFECARE; DETECTO; DETECTO". The FDA issued a decision of Substantially Equivalent on September 26, 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
September 26, 2013
Date Received
April 5, 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)
  • K130856 — BIA / VITALITY ANALYZER (November 25, 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