Manufacturer

BTL Industries

United Kingdom (ex Northern Ireland)Legal entities : BTL Industries Limited

Markets : Northern Ireland · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 47 · class I, II · latest in 2026 · see on the FDA website

EU representative : BTL ITALIA S.r.l. (Italy)

21 categories, 70 models including 70 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Muscle stimulators	Z120622	BTL Chair Applicator BTL-299-33 refs BTL EMSCULPT BTL EMSELLA BTL-6000 Super Inductive System Elite2 refs Edge applicator 899-AP-C-4 9 others Edge applicator 899-AP-C-5 EMBODY EMSCULPT NEO Focused field applicator BTL-299-2 BTL-299 Applicators2 refs Large applicator 899-AP-C-1 Large applicator BTL-299-6 Large applicator BTL-299-8 Small applicator 899-AP-C-2 Small applicator BTL-299-7	IIa MDR	EUDAMED record Report an error
Shock wave therapy equipment	Z12139001	15 mm focused transmitter3 refs Applicator Easy 844-APEA-M Applicator Magnum BTL-6000 FSWT BTL-6000 RSWT Easy 8 others BTL-6000 RSWT Elite BTL-6000 RSWT Pro BTL-6000 SWT Easy93/42 BTL-6000 SWT Topline93/42 BTL-6000 SWT Topline Power93/42 BTL-6000 X-Wave Optimal93/42 Coupling pad BTL-294-CP1F Small3 refs FSWT applicator BTL-294-1	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Electrotherapy equipment (included tens)	Z120601	BTL Walk 1-channel drop foot electrode – right BTL-806-143 refs BTL Walk Easy BTL Walk footswitch sensor BTL-806-4 BTL Walk lower leg cuff BTL-806-17 BTL Walk Pro 2 others Reference patient cable (180cm) BTL-806-483 refs Rubber electrode 120x80mm2 refs	I, IIa MDR	EUDAMED record Report an error
Treatment, diagnosis and monitoring medical beds	V080603	BTL SPINAL DECOMPRESSION PREMIUM BTL Traction Couch PRO BTL-11003 refs BTL-13003 refs BTL-1300 Basic	I MDR	EUDAMED record Report an error
Various physiotherapy and rehabilitation instruments - other	Z12069099	BTL MOTION BTL-6000 TR-Therapy Elite2 refs Capacitive applicator BTL-249-APC1 BTL-6000 TR-Therapy Accessory3 refs Patient cable BTL-249-CABN Cables BTL-2493 refs	I, IIb MDR	EUDAMED record Report an error
Medical support equipment - accessories	V0880	BTL-040-05 Trolleys BTL-040 FSWT Applicator arm Trolley BTL-092-02 Trolleys BTL-092	I MDR	EUDAMED record Report an error
Pneumatic compression equipment	Z120607	Arm 6 chambers3 refs Basic tube 12 Easy3 refs BTL-6000 Lymphastim 12 Easy3 refs	I, IIa MDR	EUDAMED record Report an error
Various physiotherapy and rehabilitation instruments - hardware accessories	Z12069080	BTL-Vac II Patient harness - size L BTL-660-73 refs Super Inductive System Seat	I MDR	EUDAMED record Report an error
Clinical/diagnostic spirometers	Z12150101	BTL Pneumotachograph BTL-08 Spiro Pro	IIa MDR	EUDAMED record Report an error
Magnetic stimulators	Z12101105	EXOMIND EXOMIND applicator BTL-699-AP-M-2	IIa MDR	EUDAMED record Report an error
Microwave therapy equipment	Z120608	BTL-6000 Microwave 250 Large field radiator BTL-218-23 refs	IIb MDR	EUDAMED record Report an error
Multi-platform laser	Z12011019	EXOLASE ONE BTL-754-A FRACTIONAL APPLICATOR BTL-754-42 refs	IIb MDR	EUDAMED record Report an error
Various instruments for functional exploration and therapeutic interventions - software accessories	Z129082	BTL CardioPoint BTL CONNECTin	IIa MDR	EUDAMED record Report an error
Assisted locomotion systems	Z12069002	R-GAIT 660-PO-M	IIa MDR	EUDAMED record Report an error
Blood pressure holter recorders	Z12050404	BTL ABPM NG Pro	IIa MDR	EUDAMED record Report an error
General purpose electrocardiographs	Z12050301	BTL Flexi 12 ECG	IIa MDR	EUDAMED record Report an error
Generic use electric medical chairs	V08020101	BTL-810-10	I MDR	EUDAMED record Report an error
Orthopaedic traction instruments - hardware accessories	Z12130280	Cervical Belt System BTL-296-02 BTL-6000 Traction accessories3 refs	I MDR	EUDAMED record Report an error
Patient positioning instruments - other	Z12011299	Belt 699-BELT-M2 refs	I MDR	EUDAMED record Report an error
Traction systems	Z12130202	BTL-6000 Traction	IIa MDR	EUDAMED record Report an error
Various physiotherapy and rehabilitation instruments - software accessories	Z12069082	Gaming Module	I MDR	EUDAMED record Report an error

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