Recall Z-2137-2016— Ergoactives, Llc
Class II · Terminated
Class II FDA medical device recall by Ergoactives, Llc, initiated 2016-01-19, terminated 2017-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.. Reason: Products are marketed without a cleared 510k..
- Recalling firm
- Ergoactives, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-19
- Terminated
- 2017-10-13
- Firm location
- Miami, FL, United States
Product description
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
Reason for recall
Products are marketed without a cleared 510k.
Data sourced from openFDA. This site is unofficial and independent of the FDA.