Ondamed Biofeedback Device Recalled for Lack of Marketing Clearance
Ondamed Inc is recalling 585 Ondamed Biofeedback Devices because they were marketed in the US without FDA clearance. Customers are advised to contact the firm for an available upgrade.
- Product
- Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
- Category
- Medical Device
- Distribution
- Distributed nationwide