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510(k) K220557

MoistureMeterD Compact, LymphScanner by Delfin Technologies, Ltd. — Product Code OBH

K220557 is an FDA 510(k) premarket notification submitted by Delfin Technologies, Ltd. for the device "MoistureMeterD Compact, LymphScanner". The FDA issued a decision of Substantially Equivalent on May 27, 2022. The device falls under product code OBH (Monitor, Extracellular Fluid, Lymphedema, Extremity), a Class II device regulated under 21 CFR 870.2770. Delfin Technologies, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2022
Date Received
February 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Extracellular Fluid, Lymphedema, Extremity
Device Class
Class II
Regulation Number
870.2770
Review Panel
GU
Submission Type

Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)

Other clearances by Delfin Technologies, Ltd.

  • K143310 — MoisturemeterD (November 19, 2015)

Other clearances for product code OBH

  • K253224 — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (January 28, 2026)
  • K230530 — SOZO Pro (May 4, 2023)
  • K180126 — SOZO (April 16, 2018)
  • K172122 — SOZO (August 11, 2017)
  • K143310 — MoisturemeterD (November 19, 2015)
  • K130338 — IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS (May 31, 2013)
  • K100811 — IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 (November 4, 2011)
  • K080825 — IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 (October 3, 2008)
  • K050415 — IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS (March 30, 2007)

FDA data resources