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510(k) K033268

SEA-BAND by Sea-Band UK , Ltd. — Product Code MVV

K033268 is an FDA 510(k) premarket notification submitted by Sea-Band UK , Ltd. for the device "SEA-BAND". The FDA issued a decision of Substantially Equivalent on January 7, 2004. The device falls under product code MVV (Device, Acupressure), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2004
Date Received
October 9, 2003
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

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  • 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