FDA Recalls Unapproved Enaly 1000 BT-12 Ozone Generator for Medical Use
William C. Domb, D.M.D., A Professional Corporation is recalling 16 units of the Enaly 1000 BT-12 Ozone Generator because the device is not approved or cleared by the FDA for medical use.
- Product
- Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to
- Category
- Medical Device
- Distribution
- 8 states