Data / Medical devices / Massager, Vacuum, Radio Frequency Induced Heat
Massager, Vacuum, Radio Frequency Induced Heat (PBX): 55 FDA-registered makers in 13 countries
55 establishments in 13 countries are registered with the FDA to make Massager, Vacuum, Radio Frequency Induced Heat (product code PBX, Class 2, 21 CFR 878.4400). 33 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 81 510(k) clearances under this code, the latest on October 13, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PBX
- Device class
- 2
- Regulation
- 878.4400
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| China | 12 |
| Israel | 8 |
| Italy | 6 |
| South Korea | 6 |
| Spain | 4 |
| Bulgaria | 1 |
| Germany | 1 |
| Poland | 1 |
| Ireland | 1 |
| Switzerland | 1 |
| Hong Kong | 1 |
| India | 1 |
Makers of Massager, Vacuum, Radio Frequency Induced Heat
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Inmode Ltd. | Yokneam Northern, Israel | Manufacturer | 7 | November 14, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bios S.R.L. | VIMODRONE Milano, Italy | Manufacturer | 4 | October 30, 2023 | 0 | 1 | 0 | api.fda.gov |
| BTL Industries JSC | Plovdiv, Bulgaria | Manufacturer | 4 | March 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| Venus Concept Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | April 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Viora Ltd. | Migdal HaEmek Northern, Israel | Complaint file establishment, Exporter to the US, Manufacturer | 4 | December 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Venus Concept Inc. | Windham, NH, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | April 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| WINBACK GO EAST Co Ltd | Wonju-si Gangwon, South Korea | Exporter to the US, Manufacturer | 4 | July 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Indiba | Sant Quirze del Valles Barcelona, Spain | Manufacturer | 3 | January 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Termosalud S.L. | Gijon Asturias(Autonomous Community), Spain | Manufacturer | 3 | May 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| WEERO Co., Ltd. | Suwon-si,Gyeonggi-do, South Korea | Manufacturer | 3 | March 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Capenergy Medical, S.L. | Sant Joan Despi Barcelona, Spain | Manufacturer | 2 | March 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cynosure, LLC | Westford, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | March 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Daeyang Medical Co. Ltd. | Wonju-si Gangwon, South Korea | Manufacturer | 2 | November 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| El.en. Electronic Engineering SPA | CALENZANO Firenze, Italy | Manufacturer | 2 | April 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Heat In A Click LLC | Dania, FL, United States | Specification developer | 2 | September 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Mectronic Medicale S.R.L. | Grassobbio Bergamo, Italy | Manufacturer | 2 | February 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Zimmer Medizinsysteme GMBH | NEU-ULM Bavaria, Germany | Manufacturer | 2 | July 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Berger & Kraft | RASZYN Mazowieckie, Poland | Manufacturer | 1 | July 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Cao Group, Inc. | W Jordan, UT, United States | Manufacturer | 1 | October 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Candela Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | September 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Domino S.R.L. | Codogne Treviso, Italy | Manufacturer | 1 | June 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| El Global Trade Ltd. | Netanya Central, Israel | Manufacturer, Specification developer | 1 | July 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ema Aesthetic Ltd | Dublin Dublin(City), Ireland | Manufacturer | 1 | April 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Endymed Medical Ltd | Caesarea Northern, Israel | Manufacturer | 1 | August 1, 2016 | 0 | 0 | 0 | api.fda.gov |
| General Vibronics, Inc. | Tempe, AZ, United States | Manufacturer | 1 | November 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Neauvia North America, Inc | Raleigh, NC, United States | Complaint file establishment, Specification developer | 1 | July 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Pollogen Ltd | Tel Aviv, Israel | Manufacturer | 1 | September 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| S&M Medical Inc. | Gwangju, South Korea | Manufacturer | 1 | March 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Leaflife Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | August 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | September 18, 2017 | 0 | 0 | 0 | api.fda.gov |
| Unibell SRL | Calco Lecco, Italy | Manufacturer | 1 | September 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Wintecare SA | Chiasso Ticino, Switzerland | Manufacturer | 1 | January 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| XOD Inc | Philadelphia, PA, United States | Specification developer | 1 | February 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| B&M S.R.L. | Milano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B.Y. Medimor Ltd | Tiberias Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Beautemax Technology Limited | Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Winkonlaser Technology Limited | Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classys Inc | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogmedix | West Boylston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Express Manufacturing, Inc | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Formatk Systems Ltd. | Tirat Hacarmel Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Fuqiang Beauty Equipment Co.,limited | Qingyuan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hong Qiangxing (shen Zhen) Electronics Limited | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing Ltd. | HENG LI, DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing, Ltd. | Kwai Chung, N.T., Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Mansfield, Bridgemedica | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ros Estetica SL | Castelldefels Barcelona, Spain | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Rainbow Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shen Zhen HanShine Technology Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ShenB Co Ltd | Seongdong-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Margotan Tech Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Peninsula Medical Group | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Syrma Johari MedTech Limited | Jodhpur Rajasthan, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Usr Electronic Systems (1987) Ltd | Karmiel Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou PZ Laser Slim Technology Co., Ltd | Zhengzhou City Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.