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TB12 VIBRATING PLIABILITY ROLLER
DREAM FACTORY INC. · Model VPLI-RED-02A · UDI-DI 04580657301003
10
510(k) clearances
163
Adverse events (4 deaths)
10
Recalls
791
Facilities
Description
Offers people of all ages, gender and abilities the benefits to improve the body’s overall performance, flexibility, and range of motion to prevent injury and thus improve overall well being.
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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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.