Tesla BioHealing, Inc.

Warning LetterOpen

James Zhou Liu CEO Tesla BioHealing, Inc. 111 McCoy Street Milford , DE 19963-2309 United StatesFEI 3023229437Issued Aug 10, 2023Division of Medical Device and Radiological Health Operations East

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3023229437.

Violations10

Issue DateAug 10, 2023

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Tesla BioHealing, Inc.
Location: James Zhou Liu CEO Tesla BioHealing, Inc. 111 McCoy Street Milford , DE 19963-2309 United States
FEI Number: 3023229437
Country: United States
Issue Date: August 10, 2023
Issuing Office: Division of Medical Device and Radiological Health Operations East
Product Type: Medical Devices
Status: Open

Summary

Tesla BioHealing, Inc. was warned for manufacturing and marketing the Tesla MedBed Generator and Tesla BioHealer as unapproved medical devices intended to treat serious conditions including terminal cancers, stroke paralysis, Lyme Disease, Alzheimer's, and Epilepsy by activating cellular self-repair mechanisms through "Life Force Energy." The company violated federal law by failing to obtain required premarket approval (PMA) or investigational device exemption (IDE) authorization before commercializing these devices, rendering them adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The FDA inspection was conducted at the company's Milford, Delaware facility from March 20-23, 2023, and the warning letter was issued August 10, 2023.

Tesla BioHealing, Inc. FDA Warning Letter, August 10, 2023