FDA Letter API

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