WHOOP, Inc.
Letter data
- Company
- WHOOP, Inc.
- Recipient
- Will Ahmed | Chief Executive Officer | WHOOP, Inc. | One Kenmore Sq. Suite 601 | Boston | , | MA | 02215 | United States
- Issue date
- 2026-06-17
- Posted date
- Not available
- FDA office
- Center for Devices and Radiological Health
- Subject
- Not available
- Product
- Medical Devices
- CMS ID
- 709755
- Reference number
- Not available
- FEI
- Not available
- Inspection dates
- Not available
Normalized citations
21 CFR: None found
21 U.S.C.: None found
Related FDA links
No related FDA letter link is present in the source index.
Full source text
CLOSEOUT LETTER
WHOOP, Inc.
MARCS-CMS 709755 —
June 17, 2026
More Warning Letters
Warning Letters
About Warning and Close-Out Letters
Product:
Medical Devices
Recipient:
Recipient Name
Will Ahmed
Recipient Title
Chief Executive Officer
WHOOP, Inc.
One Kenmore Sq. Suite 601
Boston
,
MA
02215
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mr. Ahmed:
Based on changes your firm has made to your “Blood Pressure Insights” product (“BPI”) and its labeling in response to our Warning Letter dated July 14, 2025, and consistent with the Food and Drug Administration’s updated guidance document,
General Wellness: Policy for Low Risk Devices
,
1
FDA does not intend to enforce the device statutory and regulatory requirements for your BPI product as modified.
We note that this letter is specific to your BPI product as modified and not to any other product, feature or other modifications to BPI. If you have any questions about future modifications to BPI, please contact Stephen Browning.
Sincerely,
/S/
Angela C. Krueger
Deputy Director for Regulatory Policy
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Food and Drug Administration
1
This guidance describes a policy where FDA does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and various post-market requirements for devices under the FD&C Act. FDA issued updates to this guidance on January 6, 2026.
Content current as of:
06/23/2026
Regulated Product(s)
Medical Devices