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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Wello Inc.

Issued · Posted by FDA

FDA published a close-out letter on Oct 28, 2024. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The labels of the welloStationX devices do not bear such a UDI.

Passage 2

has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these devices.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 801.20(a)
  • 21 CFR 801.3
  • 21 CFR 801.40(a)(1)
  • 21 CFR 801.40(a)(2)
  • 21 CFR 801
  • 21 CFR 830
  • 21 CFR 830.300(a)
  • 21 CFR 830.3