FDA.reportPublic FDA data

Deep-tissue electromagnetic stimulation system, professional

Definition
An assembly of devices designed to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis); 2) treat body pain (musculoskeletal, postsurgical); and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of a therapeutic deep heat. It includes a mains electricity (AC-powered) control unit with rechargeable battery alternative, application pads/flat coils intended to emit EM radiation to the treatment site (e.g., joint), and carrying case for portability. It is not intended to apply an electric current directly to the body. The system is intended to be used in a clinical setting only.
GUDID devices
13
Last updated
2020-10-15 08:07:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B108899AP2M3MUS00BTL Chair ApplicatorBTL INDUSTRIES LIMITED899-AP-M-32020-10-07
B108899AP2M2MUS00Small applicatorBTL INDUSTRIES LIMITED899-AP-M-22020-10-02
04053815076698CoolToneZimmer MedizinSysteme GmbH50342019-12-04
04053815074151emFieldProZimmer MedizinSysteme GmbH50322019-07-12
B108299AP26ENUS011030BTL-299-6BTL INDUSTRIES LIMITEDBTL-299-62019-07-09
B108299AP27ENUS0100Small applicatorBTL INDUSTRIES LIMITEDBTL-299-72019-07-09
B108799PO2166ENUS0130BTL EMSCULPTBTL INDUSTRIES LIMITEDBTL EMSCULPT2019-07-09
B108299AP26ENUS011000BTL-299-6BTL INDUSTRIES LIMITEDBTL-299-62018-02-08
B108299AP26ENUS011010BTL-299-6BTL INDUSTRIES LIMITEDBTL-299-62018-06-25
B108299AP26ENUS011020BTL-299-6BTL INDUSTRIES LIMITEDBTL-299-62019-01-08
B108799PO2166ENUS0100BTL EMSCULPTBTL INDUSTRIES LIMITEDBTL EMSCULPT2018-02-08
B108799PO2166ENUS0110BTL EMSCULPTBTL INDUSTRIES LIMITEDBTL EMSCULPT2018-06-25
B108799PO2166ENUS0120BTL EMSCULPTBTL INDUSTRIES LIMITEDBTL EMSCULPT2019-01-08