2k Innovations Inc.

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1805-2017Class IIVolt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wrapsApril 15, 2016
Z-1808-2017Class IIVolt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wrapsApril 15, 2016
Z-1809-2017Class IIVolt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wrapsApril 15, 2016
Z-1806-2017Class IIVolt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wrapsApril 15, 2016
Z-1810-2017Class IIVolt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wrapsApril 15, 2016
Z-1811-2017Class IIVolt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wrapsApril 15, 2016
Z-1804-2017Class IIVolt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wrapsApril 15, 2016
Z-1812-2017Class IIVolt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wrapsApril 15, 2016
Z-1803-2017Class IIVolt Resistance Heated Lower Back Garment Deep penetrating heat garment and wrapsApril 15, 2016
Z-1807-2017Class IIVolt Resistance Heated Elbow Garment Deep penetrating heat garment and wrapsApril 15, 2016
Z-1813-2017Class IIVolt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wApril 15, 2016
Z-1802-2017Class IIVolt Resistance Heated Neck Garment Deep penetrating heat garment and wrapsApril 15, 2016