Recall Z-1576-2014— William C. Domb, D.M.D., A Professional Corporation
Class II · Terminated
Class II FDA medical device recall by William C. Domb, D.M.D., A Professional Corporation, initiated 2014-04-23, terminated 2015-01-08. FDA's recall record names no specific 510(k) clearance for this event. 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 ozone occurs in a reaction cell excited by a high voltage potential. A control circuit allows the user to manually adjust the ozone output between 40-100% of its rated output.. Reason: William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use..
- Recalling firm
- William C. Domb, D.M.D., A Professional Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-23
- Terminated
- 2015-01-08
- Firm location
- Upland, CA, United States
Product description
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 ozone occurs in a reaction cell excited by a high voltage potential. A control circuit allows the user to manually adjust the ozone output between 40-100% of its rated output.
Reason for recall
William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.