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510(k) K900588

ACU-BAND ACCUPRESSURE WRIST BAND by Euro-Am Pharma, Inc. — Product Code MVV

K900588 is an FDA 510(k) premarket notification submitted by Euro-Am Pharma, Inc. for the device "ACU-BAND ACCUPRESSURE WRIST BAND". The FDA issued a decision of Substantially Equivalent on February 22, 1990. The device falls under product code MVV (Device, Acupressure), a Class U device. Euro-Am Pharma, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1990
Date Received
February 7, 1990
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 by Euro-Am Pharma, Inc.

  • K912620 — OPOMAT MANUAL RESUSCITATOR VENTILATOR (December 4, 1991)

Other clearances for product code MVV

  • K220289 — FridaMom Anti-Nausea Bands (June 29, 2022)
  • K211823 — Bonine Acupressure Bands (September 1, 2021)
  • 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)

FDA data resources