Instruments for functional explorations and therapeutic interventionsPhysiotherapy and rehabilitation instrumentsVarious physiotherapy and rehabilitation instruments
Various physiotherapy and rehabilitation instruments - hardware accessories
EMDN code Z12069080
Manufacturers registered in Europe (EUDAMED) 28
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 110
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Avanos Medical, Inc. | United States | Game Ready Med4 Elite Game Ready Med4 Accessory Kit GAME READY* Med4 Elite* Accessory Kit Med4Elite Accessories Game Ready Ankle Wrap - Extra Large - Rental | registered |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal | registered |
| DJO, LLC | United States | DONJOY AIRCAST | registered |
| Breg, Inc. Present in Europe in other categories | United States | BREG | K070402 (2007) |
| Shanghai Youwen Medical Technology Co.,Ltd. | China | Youwen | registered |
| Zenith Technical Innovations Present in Europe in other categories | United States | Therm-X | registered |
| THERMOTEK, INC. | United States | ThermoTek WRAP,KN/FL,SG GRD,CRCMF,QTY 10 CTN ArTek Sport Wrap ThermoTek WRAP, UNIVERSAL U, SPU, UF ThermoTek WRAP, HIP, STND, SPU, UF, QTY 10 CTN ThermoTek WRAP, KNEE-HL, DLX, SG,GD,SPU, UF ThermoTek WRAP, KNEE, MED, SPU, UF,QTY 10 CTN | K945853 (1995) |
| Gentherm Medical, LLC Present in Europe in other categories | United States | Cold Therapy Temp-Pads® Maxi-Therm®Lite Cold Therapy Temp Pads® Penguin Cold Therapy® Plastipad® Pediatric Size Maxi-Therm® | registered |
| Chengdu Cryo-Push Medical Technology Co.,Ltd | China | CRYOPUSH Dr. Aktive CryoRx | registered |
| OSSUR Americas | United States | Cold Rush Cold Rush Compact | registered |
| INNOVATIVE MEDICAL EQUIPMENT, LLC | United States | ThermaZone | registered |
| Adroit Medical Systems, Inc. | United States | Soft-Temp HTP1500 HTP1500 Accessory Accessory; HTP-1500 Replacement Cap Accessory; HTP1500 Accessory; HTP1500 Bed Bracket | K970197 (1997) |
| Bio Compression Systems, Inc. Present in Europe in other categories | United States | Bio Compression Systems 4 Chamber Cryo Hand/Wrist - Black Bio Compression Systems 4 Chamber Cryo Leg Large Bio Compression Systems BioCryo Back Bio Compression Systems 4 Chamber Cryo Ankle - Black Bio Compression Systems 4 Chamber Cryo Leg Medium - Black Bio Compression Systems 4 Chamber Cryo Knee Cylinder - Black | K961425 (1996) |
| PRESTIGE AMERITECH, LTD. | United States | PremierPro | registered |
| Polar Products, Inc. | United States | Polar Products | registered |
| Manamed, Inc. | United States | ManaMed ManaMed Inc ManaCold Platinum Unit 2.0 ManaCold Platinum Hip Pad 2.0 ManaCold Platinum Knee Pad 2.0 ManaCold Platinum Back Pad 2.0 | registered |
| C2DX, INC. Present in Europe in other categories | United States | Mul-T-Pad T/Pump TPS2 T/Pad TPIV TPT9 | registered |
| OWENS & MINOR DISTRIBUTION, INC. | – | Medichoice | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | Mul-T-Pad T/Pump T/PAD | registered |
| HYPOTHERMIA DEVICES, INC. | – | Kelvi | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | MEDLINE | registered |
| VIVE HEALTH LLC Present in Europe in other categories | United States | Vive | registered |
| Top Shelf Manufacturing, LLC Present in Europe in other categories | United States | Top Shelf Orthopedics | registered |
| ULTRA PAIN PRODUCTS INC | United States | ULTRAICE | registered |
| Advanced Ambulatory, Inc. | United States | AqueCool | registered |
| Shenzhen Shuichang Technology Co., Ltd | China | Cold Therapy System | registered |
| Fuzhou Blue Crystal Industrial Co.,Ltd. | – | BCI | registered |
| Hilotherm GmbH | Germany | Lower face cuff without link Lower face cuff with link HILOTHERM Homecare | registered |
| NEURON GUARD SRL Present in Europe in other categories | Italy | CB240_Aurora | registered |
| NormaTec Industries, LP | United States | Hyperice / NormaTec | registered |
| R2 Technologies, Inc. | United States | Dermal Cooling System | registered |
| Unite Medical, LLC | United States | RegeniCool™ Pro | registered |
| Zhangzhou Easepal Medical Science And Technology Co., Ltd. | China | Reefan | registered |
| Aquilo Sports L.L.C. | United States | Aquilo Sports | registered |
| Beijing Tsinghorse Technology Co., Ltd | – | CLIFFLAG Cold&hot Therapy System | registered |
| Dynatronics Corp. | United States | Dynatron Solaris Plus ThermoStim Probe | registered |
| Encore Medical, L.P. | United States | AIRCAST | registered |
| Ermi LLC | United States | Therminater | registered |
| NICE RECOVERY SYSTEMS LLC | United States | NICE | registered |
| WALGREEN CO. | – | Walgreens | registered |
| Xiamen Weiyou Intelligent Technology Co., Ltd. Present in Europe in other categories | China | FORCE X | registered |
| ZAMAR MEDICAL d.o.o. | Croatia | Z-ONE | registered |
| ACOT PLASTICS (XIAMEN) CO., LTD. | China | – | registered |
| ALLMAY INTERNATIONAL LIMITED | Hong Kong SAR China | – | registered |
| AVANUTRI EQUIPAMENTOS DE SAUDE LTDA | Brazil | – | registered |
| Accumed Intl., Inc. | United States | – | registered |
| All Quality & Services, Inc. | United States | – | registered |
| Allmay Bodywear (Shenzhen) Co., Ltd | China | – | registered |
| Ascentron, Inc. | United States | – | registered |
| Brace Align | United States | – | registered |
| Brain Health Spectrum (Chengdu) Artificial Intelligence Tech | China | – | registered |
| CRYODRESSING, INC | United States | – | registered |
| Chengdu Ruinuo Meijer Medical Instrument Co., Ltd. | China | – | registered |
| Comfortland International, LLC | United States | – | registered |
| Critical Care Diagnostics, Inc | United States | – | registered |
| Cryo-Dynamics Inc. | United States | – | registered |
| DIKAKU INDUSTRIAL CO.,LIMITED | China | – | registered |
| DONGGUAN KAISER TECHNOLOGY CO., LTD Present in Europe in other categories | China | – | registered |
| Danyang Sunmed Healthcare Corporation Present in Europe in other categories | China | – | registered |
| Dylan Lucas International Inc | Canada | – | registered |
| FOFO medical co.,ltd | China | – | registered |
| Foshan Hongfeng Co., Ltd. Present in Europe in other categories | China | – | registered |
| GABOSS INTERNATIONAL LIMITED | China | – | registered |
| Gener8 | United States | – | registered |
| HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD | China | – | registered |
| Hangzhou Yunchi Technology Co., LTD | China | – | registered |
| Hebei Ruinuo Medical Instrument Co., Ltd | China | – | registered |
| Hypothermia Devices, Inc. (dba Kelvi) | United States | – | registered |
| IMEX, LLC | United States | – | registered |
| Ivy Technology | United States | – | registered |
| JANDTY HEALTH INC. | Taiwan | – | registered |
| JUST KEEP HEALTHY CO., LTD. | Cambodia | – | registered |
| Jabil Inc. | United States | – | registered |
| Jkh Health Co., Ltd. Present in Europe in other categories | China | – | registered |
| Joicom Corporation | United States | – | registered |
| KEYSTONE MANUFACTURING, LLC | United States | – | registered |
| LU MARK ENTERPRISES, INC. | Taiwan | – | registered |
| Leison Medical & Healthcare Products Co., Ltd | China | – | registered |
| Lianmaida Electric (Dongguan) Co., Ltd. | China | – | registered |
| Multi Radiance Medical Present in Europe in other categories | United States | – | registered |
| Ningbo Chendong Sports & Sanitarian Co.,ltd | China | – | registered |
| Ningbo Dearevery Electrical Technology CO., LTD. | China | – | registered |
| Ningbo Jinhui Photoelectricity Technology Co., Ltd | China | – | registered |
| Ningbo MPF Manufacturing Co.,Ltd. | China | – | registered |
| ONLYCARE INC Present in Europe in other categories | United States | – | registered |
| OTE International, Inc. | Taiwan | – | registered |
| PRIDE Industries | United States | – | registered |
| Pain Management Technologies | United States | – | K213097 (2022) |
| Platinum Focus Group Ltd. | United Kingdom | – | registered |
| Polo Custom Products | United States | – | registered |
| QINGDAO KUNTENG MEDICAL INSTRUMENT CO LTD | China | – | registered |
| RAYE'S, Inc dba Sizewise Manufacturing a wholly owned subsid | United States | – | registered |
| RECHAR INC. | United States | – | registered |
| Root Land Limited | Hong Kong SAR China | – | registered |
| Shanghai Honca Import and Export co.,Ltd | China | – | registered |
| Shenzhen Eyco Technology Co.,Ltd | China | – | registered |
| Shenzhen Ruiyi Business Technology Co., Ltd. | China | – | registered |
| Shenzhen Ruizhang Industrial Co., Ltd. | China | – | registered |
| Shenzhen Shufang Electronic Commerce Co., Ltd. | China | – | registered |
| Shenzhen Yicai Health Technology Co., Ltd. | China | – | registered |
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