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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

CountryMakers
United States12
China12
Israel8
Italy6
South Korea6
Spain4
Bulgaria1
Germany1
Poland1
Ireland1
Switzerland1
Hong Kong1
India1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Inmode Ltd.Yokneam Northern, IsraelManufacturer7November 14, 2024000api.fda.gov
Bios S.R.L.VIMODRONE Milano, ItalyManufacturer4October 30, 2023010api.fda.gov
BTL Industries JSCPlovdiv, BulgariaManufacturer4March 29, 2019000api.fda.gov
Venus Concept Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer4April 27, 2022000api.fda.gov
Viora Ltd.Migdal HaEmek Northern, IsraelComplaint file establishment, Exporter to the US, Manufacturer4December 9, 2020000api.fda.gov
Venus Concept Inc.Windham, NH, United StatesComplaint file establishment, Manufacturer, Specification developer4April 27, 2022000api.fda.gov
WINBACK GO EAST Co LtdWonju-si Gangwon, South KoreaExporter to the US, Manufacturer4July 19, 2023000api.fda.gov
IndibaSant Quirze del Valles Barcelona, SpainManufacturer3January 24, 2025000api.fda.gov
Termosalud S.L.Gijon Asturias(Autonomous Community), SpainManufacturer3May 28, 2025000api.fda.gov
WEERO Co., Ltd.Suwon-si,Gyeonggi-do, South KoreaManufacturer3March 13, 2026000api.fda.gov
Capenergy Medical, S.L.Sant Joan Despi Barcelona, SpainManufacturer2March 28, 2023000api.fda.gov
Cynosure, LLCWestford, MA, United StatesComplaint file establishment, Manufacturer, Specification developer2March 25, 2020000api.fda.gov
Daeyang Medical Co. Ltd.Wonju-si Gangwon, South KoreaManufacturer2November 1, 2022000api.fda.gov
El.en. Electronic Engineering SPACALENZANO Firenze, ItalyManufacturer2April 2, 2026000api.fda.gov
Heat In A Click LLCDania, FL, United StatesSpecification developer2September 26, 2022000api.fda.gov
Mectronic Medicale S.R.L.Grassobbio Bergamo, ItalyManufacturer2February 17, 2023000api.fda.gov
Zimmer Medizinsysteme GMBHNEU-ULM Bavaria, GermanyManufacturer2July 15, 2024000api.fda.gov
Berger & KraftRASZYN Mazowieckie, PolandManufacturer1July 30, 2021000api.fda.gov
Cao Group, Inc.W Jordan, UT, United StatesManufacturer1October 28, 2020000api.fda.gov
Candela CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer1September 12, 2016000api.fda.gov
Domino S.R.L.Codogne Treviso, ItalyManufacturer1June 6, 2022000api.fda.gov
El Global Trade Ltd.Netanya Central, IsraelManufacturer, Specification developer1July 14, 2017000api.fda.gov
Ema Aesthetic LtdDublin Dublin(City), IrelandManufacturer1April 15, 2025000api.fda.gov
Endymed Medical LtdCaesarea Northern, IsraelManufacturer1August 1, 2016000api.fda.gov
General Vibronics, Inc.Tempe, AZ, United StatesManufacturer1November 21, 2024000api.fda.gov
Neauvia North America, IncRaleigh, NC, United StatesComplaint file establishment, Specification developer1July 30, 2021000api.fda.gov
Pollogen LtdTel Aviv, IsraelManufacturer1September 10, 2025000api.fda.gov
S&M Medical Inc.Gwangju, South KoreaManufacturer1March 9, 2026000api.fda.gov
Shenzhen Leaflife Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1August 14, 2025000api.fda.gov
Shenzhen Jie Zhong Lian Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1September 18, 2017000api.fda.gov
Unibell SRLCalco Lecco, ItalyManufacturer1September 10, 2018000api.fda.gov
Wintecare SAChiasso Ticino, SwitzerlandManufacturer1January 29, 2019000api.fda.gov
XOD IncPhiladelphia, PA, United StatesSpecification developer1February 27, 2025000api.fda.gov
B&M S.R.L.Milano, ItalyManufacturer0000api.fda.gov
B.Y. Medimor LtdTiberias Northern, IsraelContract manufacturer0000api.fda.gov
Beijing Beautemax Technology LimitedBeijing, ChinaContract manufacturer0000api.fda.gov
Beijing Winkonlaser Technology LimitedBeijing, ChinaContract manufacturer0000api.fda.gov
Classys IncAnyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
CogmedixWest Boylston, MA, United StatesContract manufacturer0000api.fda.gov
Express Manufacturing, IncSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Formatk Systems Ltd.Tirat Hacarmel Northern, IsraelManufacturer0000api.fda.gov
Guangdong Fuqiang Beauty Equipment Co.,limitedQingyuan Guangdong, ChinaManufacturer0000api.fda.gov
Hong Qiangxing (shen Zhen) Electronics LimitedShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Modern Medical Equipment Manufacturing Ltd.HENG LI, DONGGUAN Guangdong, ChinaContract manufacturer0000api.fda.gov
Modern Medical Equipment Manufacturing, Ltd.Kwai Chung, N.T., Hong KongContract manufacturer0000api.fda.gov
Paragon Medical - Mansfield, BridgemedicaMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Ros Estetica SLCastelldefels Barcelona, SpainContract manufacturer0000api.fda.gov
Shenzhen Rainbow Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shen Zhen HanShine Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
ShenB Co LtdSeongdong-gu Seoul, South KoreaManufacturer0000api.fda.gov
Shenzhen Margotan Tech Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Peninsula Medical GroupShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Syrma Johari MedTech LimitedJodhpur Rajasthan, IndiaContract manufacturer0000api.fda.gov
Usr Electronic Systems (1987) LtdKarmiel Northern, IsraelContract manufacturer0000api.fda.gov
Zhengzhou PZ Laser Slim Technology Co., LtdZhengzhou City Henan, ChinaManufacturer0000api.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.