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TumEase B2

by Mumease

TumEase B2 is a device classified as Unclassified made by Mumease, cleared under FDA 510(k) K193374 on 4 Mar 2020 and listed in FDA GUDID since 11 May 2020 (UDI-DI 00860002270210), active as of 22 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 22 Oct 2026

Documents

510(k) K193374

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860002270210 UDI-DI Date11 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193374 Date4 Mar 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193374 decided 4 Mar 2020 Active
  • FDA GUDID UDI-DI 00860002270210 listed 11 May 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193374
  2. Listed FDA GUDID 00860002270210

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TumEase
Generic name
Anti-nausea acupressure wristband
Model / reference
B2
Primary DI / UDI-DI
00860002270210
510(k) Number
FDA product code
MVV
GMDN term
Anti-nausea acupressure wristband
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Category: Acupressure wristband

Cleared under the same submission (K193374)

and 2 more cleared under K193374

Other devices from Mumease

  • TumEase B6

    Unclassified

  • MumEase AB1

    Unclassified

  • TumEase B1

    Unclassified

  • TumEase B3

    Unclassified

See all devices from Mumease →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)