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Health Optimizer 4.X

by Welldoc 3 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB5530701001OTC0 UDI-DI Date14 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Health Optimizer
Generic Name
Home pharmaceutical management support software
Model / Reference
4.X
Primary DI / UDI-DI
B5530701001OTC0
510(k) Number
FDA Product Code
MRZ
GMDN Term
Home pharmaceutical management support software
Device Class
Class II
Regulation Number
880.5725
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K193654)

Other devices from Welldoc

See all devices from Welldoc →

Properties

  • Over-the-Counter
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No