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510(k) K220289

FridaMom Anti-Nausea Bands by Fridababy, LLC — Product Code MVV

K220289 is an FDA 510(k) premarket notification submitted by Fridababy, LLC for the device "FridaMom Anti-Nausea Bands". The FDA issued a decision of Substantially Equivalent on Jun 29, 2022. The device falls under product code MVV (Device, Acupressure), a Class U device.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 29, 2022
Date Received
Feb 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Device, Acupressure
Device Class
Class U
Review Panel
NE
Submission Type
Enforcement Discretion

Other clearances for product code MVV

  • K211823 — Bonine Acupressure Bands (Sep 1, 2021)
  • K193374 — TumEase Acupressure Bracelets (Mar 4, 2020)
  • K142471 — Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist… (Dec 1, 2014)
  • K110821 — BARF BAND (Feb 27, 2012)
  • K110563 — PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT… (Apr 8, 2011)
  • K070766 — PSI BANDS (Jul 26, 2007)
  • K053509 — ACUBAND ACUPRESSURE WRIST BAND DEVICE (Aug 16, 2006)
  • K051397 — BIOBANDS (Sep 16, 2005)
  • K041766 — EZY-TRAVEL WRISTBAND (Nov 26, 2004)
  • K041877 — ACU-STRAP MOTION SICKNESS BAND (Oct 8, 2004)

FDA data resources

Source: FDA 510(k) database entry for K220289. Report a data issue: hello@regdatalab.com.