Warning Letter: Tesla BioHealing, Inc. (MARCS-CMS 658010)
fda document · 2023
LINK
SUMMARY
FDA warning letter addressed to 'Dear Mr. Liu' at Tesla BioHealing, Inc., 111 McCoy Street, Milford, DE 19963-2309, following a March 20-23, 2023 inspection. It identifies James Zhou Liu as CEO and recipient, states the firm manufactures the Tesla MedBed Generator and Tesla BioHealer, and quotes the company's own website and product labels claiming the devices generate 'pure Life Force Energy' / biophotons that activate 'cellular self-repair mechanisms' for a wide variety of chronic illnesses including terminal cancers, stroke paralysis, Lyme disease, Alzheimer's/dementia, and epilepsy. FDA found the devices adulterated (no PMA or IDE) and misbranded (no 510(k) clearance; marketed for uses beyond the 21 CFR 890.5500 infrared-lamp exemption they were registered under, since the devices have no heating element), plus multiple Quality System regulation (21 CFR Part 820) violations in design validation, complaint handling, corrective/preventive action, and production controls, and a failure to list the device names in the firm's annual FDA registration. The letter gives the firm 15 business days to respond and warns of potential seizure, injunction, or civil penalties for failure to address the violations. The live FDA page returns HTTP 403 to automated fetches; this record was verified from the Wayback Machine capture at http://web.archive.org/web/20260312143008/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tesla-biohealing-inc-658010-08102023, whose full text was fetched and read directly.
NOTES
The full warning-letter text, as archived, documents the FDA’s inspection findings, the exact marketing language quoted from the company’s website, Intended Use Chart, and product labels, and the specific regulatory violations (adulteration under 21 U.S.C. section 351(f)(1)(B), misbranding under 21 U.S.C. section 352(o), and Quality System regulation violations under 21 CFR Part 820). No FDA close-out letter resolving this warning letter was found in the sources consulted for this case.