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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 September 1, 2021. The device falls under product code MVV (Device, Acupressure), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2021
Date Received
June 14, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Acupressure
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

Other clearances for product code MVV

  • K220289 — FridaMom Anti-Nausea Bands (June 29, 2022)
  • K193374 — TumEase Acupressure Bracelets (March 4, 2020)
  • K142471 — Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist St (December 1, 2014)
  • K110821 — BARF BAND (February 27, 2012)
  • K110563 — PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRI (April 8, 2011)
  • K070766 — PSI BANDS (July 26, 2007)
  • K053509 — ACUBAND ACUPRESSURE WRIST BAND DEVICE (August 16, 2006)
  • K051397 — BIOBANDS (September 16, 2005)
  • K041766 — EZY-TRAVEL WRISTBAND (November 26, 2004)
  • K041877 — ACU-STRAP MOTION SICKNESS BAND (October 8, 2004)

FDA data resources