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Vave VA-0175

by Vave Health Inc

Vave VA-0175 is a Class II device made by Vave Health Inc, cleared under FDA 510(k) K191541 on 10 Jul 2019 and listed in FDA GUDID since 14 Jun 2021 (UDI-DI 00850001977050), 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) K191541

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 Number00850001977050 UDI-DI Date14 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191541 Date10 Jul 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191541 decided 10 Jul 2019 Active
  • FDA GUDID UDI-DI 00850001977050 listed 14 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191541
  2. Listed FDA GUDID 00850001977050

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vave
Generic name
Portable/mobile rechargeable battery pack
Model / Ref / Catalog
VA-0175
Primary DI / UDI-DI
00850001977050
510(k) Number
FDA product code
ITX, IYO, IYN
GMDN term
Portable/mobile rechargeable battery pack
Device class
Class II
Regulation number
892.1570, 892.1560, 892.1550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Battery box

Cleared under the same submission (K191541)

Similar devices

Also classified as Battery box.

Similar devices

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

Other devices from Vave Health Inc

  • Vave VA-0182, VUSP3

    Class II

  • Vave VA-0330

    Class II

  • Vave VA-0327

    Class II

  • Vave VBT

    Class II

See all devices from Vave Health Inc →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)