TensCare
TENSCARE LIMITED · Model Shockwave · UDI-DI 05033435133796
Description
Shockwave is a solenoid drive activates a bullet body inside the therapeutic handle. When the bullet body collides with the therapeutic head, the impact energy is converted into a radial ballistic shock wave pulse, which is focussed to create the characteristics required to have a good therapeutic effect for musculoskeletal disorders. The innovative technology has a compact design with no need for a compressor. The clear colour display shows all relevant treatment parameters and offers touch screen operation for ease of use during treatment. Variable frequencies and various applicator heads allow treatment to be adapted to the particular condition of the patient.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-23 | Therabody, Inc | Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received reports alleging the prod |
| 2025-10-09 | Pivotal Health Solutions, Inc. | The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to s |
| 2025-10-09 | Pivotal Health Solutions, Inc. | The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to s |
| 2025-04-09 | Richard Wolf GmbH | The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. |
| 2020-12-15 | Wahl Clipper Corp | The connection between the massager and heat element can overheat causing smoke or spark, which may pose a fire hazard |
| 2011-08-30 | King International | The covered rotating mechanism can catch on user's clothing, jewelry (e.g. necklace), and hair. There have been reports of one death and a strangulation associated with using the |
| 2008-06-18 | Sybaritic, Inc | Misbranded and sale without pre-market notification. |
| 2005-11-01 | Wahl Clipper Corp | The massager may develop a crack in the cord insulation where it exits out of the strain relief. A crack in the insulation may expose live conductors resulting in a possible elect |
| 2005-11-01 | Wahl Clipper Corp | The massager may develop a crack in the cord insulation where it exits out of the strain relief. A crack in the insulation may expose live conductors resulting in a possible elect |
| 2004-12-10 | Wahl Clipper Corp | The housing of the massager's heating applicator attachment may crack during use. If the plastic housing cracks and breaks it could expose the user to live electrical connections |
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