tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
TOMSCOUT
MARCS-CMS 720850 —
March 27, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Lim Tong Moi
Recipient Title
Partner
TOMSCOUT
163 Still Road
Boon Court
423996
Singapore
abuse@tomscout.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Lim Tong Moi:
The Food and Drug Administration (FDA) has completed an evaluation of TOMSCOUT corrective actions in response to our Warning Letter CMS #720850, dated December 16th, 2025. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Michael J. Hoffmann
Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
cc: Shopify, Inc.
abuse@shopify.com
cc: hello@tomscout.com
Content current as of:
04/07/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
WAVi Co.
MARCS-CMS 658549 —
February 25, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
David S. Oakley
Recipient Title
Chief Executive Officer
WAVi Co.
3857 N Steele St. Ste 1293
Denver
,
CO
80205-4996
United States
david@wavimed.com
Issuing Office:
Division of Medical Device and Radiological Health Operations West
United States
Secondary Issuing Offices
United States
Dear Mr. Oakley:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 658549, dated October 20, 2023). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Barbara C. Marsden
Acting Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
cc: Mason Carter, mason.carter@wavimed.com
Content current as of:
03/03/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
WHOOP, Inc.
MARCS-CMS 709755 —
June 17, 2026
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