Home › Device types › ISA
Massager, Therapeutic, Electric
FDA product code ISA · Class 1 · Physical Medicine
1,366
Registered devices
163
Adverse events
10
Recalls
100
510(k) clearances
Devices with this code
3H — 3H, Co., LtdALPHAMED — Shenzhen Urion Technology Co., LtdHomedics — Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.ComfortWave — Sidmar Manufacturing, Inc.CONAIR CORPORATION — CONAIR CORPORATIONMomcozy — Shenzhen Lutejiacheng Supply Chain Management Co., Ltd.Human Touch — Human Touch, LLCHuman Touch — Human Touch, LLCRENPHO — Joicom CorporationCONAIR — CONAIR CORPORATIONHomedics — Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.THERMAGE FLX — SOLTA MEDICALHuman Touch — Human Touch, LLCHuman Touch — Human Touch, LLCFormaI — INMODE M.D LTDHuman Touch — Human Touch, LLC3H — 3H, Co., LtdBC Applicator — VIORA LTDSharper Image — Merchsource, LLCCONAIR — CONAIR CORPORATIONRENPHO — Joicom Corporation3H — 3H, Co., LtdSharper Image — Merchsource, LLCHomedics — Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.
Recent 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 repor |
| 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 |
| 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 |
| 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 |
| 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 associ |
| 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 |
| 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 |
| 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 el |
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