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# Tesla BioHealing Illegally Marketing Devices
- URL: https://www.fdaweb.com/tesla-biohealing-illegally-marketing-devices/
- Published: 2023-08-29T12:00:00.000Z
- Updated: 2026-09-14T18:53:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155197

A 3/20-3/23 FDA inspection at Tesla BioHealing in Milford, DE, found that the company manufactures the Tesla MedBed Generator and Tesla BioHealer medical devices. An 8/10 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tesla-biohealing-inc-658010-08102023?ref=fdaweb.com) says the devices are marketed with indications that they activate cellular self-repair mechanisms to treat a wide variety of chronic illnesses and diseases such as terminal cancers, stroke paralysis, Lyme disease, Alzheimer’s/dementia, and epilepsy.

The letter says Tesla does not have an approved PMA or IND in effect for its devices, making them adulterated. The devices also are misbranded, it says, because they are being marketed for a use different from the intended use of a legally marketed generic type of device.

FDA says it also found these Quality System Regulation violations:

- failing to establish and maintain procedures for validating the device design and failing to ensure that devices conform to defined user needs and intended uses;
- failing to establish quality system procedures and instructions;
- failing to establish and maintain an adequate organizational structure to ensure that devices are designed and produced under Quality System requirements;
- failing to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purpose and is capable of producing valid results; and
- failing to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, and failing to evaluate and select potential suppliers, contractors, and consultants based on their ability to meet specified requirements, including quality requirements.

Tesla was told to take prompt action to address the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections or corrective actions, and a schedule for completing them.