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Sea-Band Mama

by Sea-Band Limited

Sea-Band Mama is an anti-nausea acupressure wristband (FDA unclassified; FDA product code MVV, Device, Acupressure) made by Sea-Band Limited, cleared under FDA 510(k) K033268 on 7 Jan 2004 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00008727000372), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K033268

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00008727000372 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK033268 Date7 Jan 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K033268 decided 7 Jan 2004 Active
  • FDA GUDID UDI-DI 00008727000372 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K033268
  2. Listed FDA GUDID 00008727000372

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sea-Band
Generic name
Anti-nausea acupressure wristband
Model / reference
Mama
Primary DI / UDI-DI
00008727000372
510(k) Number
FDA product code
MVV
GMDN term
Anti-nausea acupressure wristband
Device class
U
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code MVV (Device, Acupressure).

Other devices from Sea-Band Limited

  • Sea-Band XL

    Unclassified
  • Sea-Band Adult

    Unclassified
  • Sea-Band Child

    Unclassified

Properties

Other properties (15, all answered No)