Home / 510(k) Clearances / K211823

510(k) K211823

Bonine Acupressure Bands by Wellspring Pharmaceutical Corporation — Product Code MVV

K211823 is an FDA 510(k) premarket notification submitted by Wellspring Pharmaceutical Corporation for the device "Bonine Acupressure Bands". The FDA issued a decision of Substantially Equivalent on Sep 1, 2021. The device falls under product code MVV (Device, Acupressure), a Class U device.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 1, 2021
Date Received
Jun 14, 2021
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

  • K220289 — FridaMom Anti-Nausea Bands (Jun 29, 2022)
  • 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 K211823. Report a data issue: hello@regdatalab.com.