Massager, Therapeutic, Electric
Physical Medicine · 21 CFR 890.5660
Recent MDR events
163 adverse event reports on file
- WARRENSLOVE QUANTUM/ENERGY BRACELETSJun 8, 2026InjuryWarrenslove(hongkong)limitedMW5189024
- OLYLIFE TERA P90Apr 9, 2026InjuryOlylife International Sdn BhdMW5186559
- MEDICUBE MINI BOOSTER PRO PINK AFFORDABLE AT-HOME FACIAL DEVICEMar 26, 2026InjuryApr Co., Ltd.MW5185901
- MEDICUBE MINI BOOSTER PRO PINK AFFORDABLE AT-HOME FACIAL DEVICE FOR BEGINNERS.Mar 26, 2026InjuryUnknownMW5185995
- HOMEDICSMar 16, 2026InjuryHealth Care Massage Branch Of Zhangzhou Easepal In1832894-2025-00001
- QUANTUM INTERSEGMENTAL TABLEMar 16, 2026MalfunctionPivotal Health Solutions3007278668-2026-00003
- QUANTUM INTERSEGMENTAL TABLEMar 16, 2026MalfunctionPivotal Health Solutions3007278668-2026-00004
- QUANTUM INTERSEGMENTAL TABLEMar 16, 2026MalfunctionPivotal Health Solutions3007278668-2026-00002
- QUANTUM INTERSEGMENTAL TABLEMar 10, 2026MalfunctionPivotal Health Solutions3007278668-2026-00001
- VIORA INCFeb 6, 2026InjuryViora Inc.3010927849-2026-00002
Event type breakdown
Recalls
10 recall events for this product code
- Therabody, IncOpen, ClassifiedJul 31, 2026
Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger.
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 product caught fire and other reports regarding visible smoke, melting, charger burn, burning odor, and overheating.
Z-2835-2026 · View FDA record ↗ - Pivotal Health Solutions, Inc.Open, ClassifiedNov 24, 2025
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
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 smoldering and melting of the vinyl cushion.
Z-0587-2026 · View FDA record ↗ - Pivotal Health Solutions, Inc.Open, ClassifiedNov 24, 2025
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
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 smoldering and melting of the vinyl cushion.
Z-0588-2026 · View FDA record ↗ - Richard Wolf GmbHOpen, ClassifiedMay 13, 2025
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (
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. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.
Z-1753-2025 · View FDA record ↗ - Wahl Clipper CorpTerminatedFeb 5, 2021
WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor muscle aches and pains.
The connection between the massager and heat element can overheat causing smoke or spark, which may pose a fire hazard
Z-1084-2021 · View FDA record ↗ - King InternationalTerminatedNov 10, 2011
Shoulder Flex Massage Device
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 device.
Z-0172-2012 · View FDA record ↗ - Sybaritic, IncTerminatedJun 23, 2009
Sybaritic, Inc., SlimLine Health Environment Capsule,
Misbranded and sale without pre-market notification.
Z-1423-2009 · View FDA record ↗ - Wahl Clipper CorpTerminatedJan 26, 2006
Wahl 2-Speed All-Body Massager, model 4120-1; therapeutic massager; Wahl Clipper Corporation, Sterling, IL 61081, made in China;
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 electric shock and injury to the user.
Z-0447-06 · View FDA record ↗ - Wahl Clipper CorpTerminatedJan 26, 2006
Wahl 2-Speed All-Body Massager with Heat and Discovery Channel brand 8-Way Massager with Heat, model 4196-1; therapeutic massager; Wahl Clipper Corporation, Ste
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 electric shock and injury to the user.
Z-0448-06 · View FDA record ↗ - Wahl Clipper CorpTerminatedJun 1, 2005
Discovery Channel brand 8-Way Massager with Heat; therapeutic massager; Wahl Clipper Corporation, Sterling, IL 61081, made in China
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 and pose a shock hazard.
Z-0856-05 · View FDA record ↗
Registered firms
840 firms currently registered for this product code
Fujian Ruili Electronics Co.,ltd.
Ningde Fujian, CN
Rhein Laser Technologies Co., Ltd.
wuhan Hubei, CN
Rh Usa, Inc.
LIVERMORE, CA, US
Jin Hua City Xing Bu Technology Co., Ltd
Jinhua Zhejiang, CN
Solite Wellbeing Usa Inc.
Austin, TX, US
Shenzhen Fittop Health Technology Co., Ltd.
Shenzhen Guangdong, CN
Viora Ltd.
Migdal HaEmek Northern, IL
Leadermed Group Us Corporation
Cranbury, NJ, US
Health & Health (group) Co.,ltd
Guangzhou Guangdong, CN
Hebei Youjie Medical Devices Co., Ltd
Shijiazhuang Hebei, CN
Shenzhen Eyco Technology Co.,ltd
Shenzhen Guangdong, CN
Shenzhen Weijie Intelligent Technology Company Ltd.
Shenzhen Guangdong, CN
Inmode Ltd.
Yokneam Northern, IL
Bausch & Lomb Incorporated
Rochester, NY, US
Zhejiang Mondial Electronic Technology Co., Ltd
Taizhou Zhejiang, CN
Solta Medical, Inc.
Bothell, WA, US
Shenzhen Yiguangnian Innovation Technology Co., Ltd.
Shenzhen Guangdong, CN
Shenzhen Future Electronic Co.,ltd
SHENZHEN Guangdong, CN
Beijing Nubway S&t Co.,ltd.
Beijing, CN
Astek Technology Ltd.
Tainan, TW
Btb Korea Co.,ltd
Seongnam Gyeonggi, KR
Fujian Ives Electronic Co., Ltd
Ningde Fujian, CN
Essentia Industries Ltd.
Dong Guan Guangdong, CN
Dongguan Qing Xi Essentia Industries Ltd
Dongguan Guangdong, CN
510(k) clearances
100 clearances for this product code
- TermosaludFeb 6, 2025
K243488 · VMAT PRO
- Shenzhen Dongdixin Technology Co., Ltd.Jun 5, 2024
K240358 · ShockPhysio Mobile (model SW3200 Basic)
- BTL Industries, Inc.Apr 14, 2023
K221865 · BTL-094
- Medispec, Ltd.Jan 27, 2023
K210166 · Omnispec ED1000
- Tissue Regeneration Technologies, LLC Dba AS Softwave TrtOct 12, 2022
K213120 · OW100S (model OW100S-US)
- E.M.S Electro Medical Systems S.AJul 11, 2022
K220538 · DolorClast Radial
- Tissue Regeneration Technologies, LLCMay 5, 2021
K210451 · OrthoGold 100
- Tissue Regeneration TechnologiesDec 21, 2018
K182682 · OrthoGold 100