2k Innovations Inc.
Saint Augustine, FL, US
2k Innovations Inc. appears in FDA device records in Saint Augustine, FL. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 12 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 12
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1813-2017 | Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated | |
| Z-1812-2017 | Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated | |
| Z-1811-2017 | Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated | |
| Z-1810-2017 | Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated | |
| Z-1809-2017 | Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated | |
| Z-1808-2017 | Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated | |
| Z-1807-2017 | Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated | |
| Z-1806-2017 | Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated | |
| Z-1805-2017 | Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated | |
| Z-1804-2017 | Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated | |
| Z-1803-2017 | Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated | |
| Z-1802-2017 | Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain