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Plus Handpiece

DEKA M.E.L.A. SRL · Model E098H1 · UDI-DI 08034108512679

ISA Prescription

510(k) clearances

163

Adverse events (4 deaths)

Recalls

791

Facilities

Description

The Plus Handpiece is indicated for temporary increase in local blood circulation, and activation of connective tissue. The Plus Handpiece (Type B) is capable of emitting a pulsed "air massage" on the area to be treated. The Plus Handpiece is also equipped with an Off/On button.

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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Data 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.