# FDA WARNING_LETTER - Tesla Biohealing, Inc. - March 23, 2023

Source: https://www.keypedia.com/records/warning_letter/tesla-biohealing-inc/538b2a15-b9cd-4acc-b86b-341a59d2a087

> FDA WARNING_LETTER for Tesla Biohealing, Inc. on March 23, 2023. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Tesla Biohealing, Inc.
- Inspection Date: 2023-03-23
- Product Type: Devices
- Office Name: Division of Medical Device and Radiological Health Operations East
- Summary: On August 10, 2023, the FDA issued a Warning Letter to Tesla BioHealing, Inc. following an inspection from March 20-23, 2023. The firm manufactures Tesla MedBed Generator and Tesla BioHealer medical devices, marketed with claims of activating cellular self-repair for conditions like terminal cancers, stroke paralysis, and Alzheimer's.

The devices are deemed adulterated under 21 U.S.C. § 351(f)(1)(B) because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under 21 U.S.C. § 352(o) for being introduced into interstate commerce for uses different from legally marketed infrared lamps (21 CFR 890.5500) without a 510(k) premarket notification. The devices lack a heating element and are marketed for treating various chronic illnesses, as evidenced by their website, "Intended Use Chart," and product labels.

Furthermore, the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations include:
1. Failure to establish and maintain design validation procedures (21 CFR § 820.

## Related Documents

- [483 - 2023-03-23](https://www.keypedia.com/records/483/tesla-biohealing-inc/dc55f039-2d0d-40e5-a91b-09d924e6b537)

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/joseph-s-matrisciano/62ff5cd6-c3ab-4443-bf26-f61a512f3960)
- [Vivek Pinto](https://www.keypedia.com/people/vivek-pinto/a8e103ca-4ef0-4f2c-9d95-a5123100961c)

Company: https://www.keypedia.com/companies/tesla-biohealing-inc/1ff5065b-3e68-4df9-a5ca-2191a8a35bf0

Office: https://www.keypedia.com/offices/division-of-medical-device-and-radiological-health-operations-east/360ecccc-5273-4159-86e7-9eaeb8d41456