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Happy Hearts UA-651BLE-ACCESS

by Happy Heart Care Services, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860016324107 UDI-DI Date28 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0063-2017 FDA Class II initiated 12 Sep 2016

    A&D may have shipped blood pressure monitors that were not labeled for use with small cuff.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Happy Hearts
Generic Name
Automatic-inflation electronic sphygmomanometer, non-portable
Model / Reference
UA-651BLE-ACCESS
Primary DI / UDI-DI
00860016324107
510(k) Number
FDA Product Code
DXN
GMDN Term
Automatic-inflation electronic sphygmomanometer, non-portable
Device Class
Class II
Regulation Number
870.1130
GUDID distribution status
In Commercial Distribution

Properties

  • Serial Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No