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Therabody
Therabody, Inc. · Model TheraFace Conductive Gel · UDI-DI 00840295408224
1
510(k) clearances
138
Adverse events (1 deaths)
10
Recalls
58
Facilities
Description
TheraFace Conductive Gel Intended to be used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-22 | Parker Laboratories, Inc. | Product demonstrates low viscosity. |
| 2024-02-07 | Natus Neurology Inc | Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Numb |
| 2024-02-07 | Natus Neurology Inc | Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Numb |
| 2024-01-22 | Parker Laboratories, Inc. | Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60. |
| 2021-08-24 | National Distribution & Contracting Inc | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| 2019-06-19 | Pharmaceutical Innovations, Inc. | Potential for failed stability antimicrobial effectiveness testing. |
| 2019-06-19 | Pharmaceutical Innovations, Inc. | Potential for failed stability antimicrobial effectiveness testing. |
| 2019-06-19 | Pharmaceutical Innovations, Inc. | Potential for failed stability antimicrobial effectiveness testing. |
| 2019-06-19 | Pharmaceutical Innovations, Inc. | Potential for failed stability antimicrobial effectiveness testing. |
| 2019-06-19 | Pharmaceutical Innovations, Inc. | Potential for failed stability antimicrobial effectiveness testing. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.