BTL INDUSTRIES LIMITED

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Massager, Vacuum, Radio Frequency Induced Heat (PBX) (4) Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (4) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2) Stimulator, Muscle, Powered (IPF) (1)

Premarket Exempt

Yes No

Clear

BTL-785F - B108785PO5MUS00 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 1

BTL-785F - B108785POFMUS00 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

EMFEMME V24 tip - B108785TIPV24MUS00 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

EMFEMME V30 tip - B108785TIPV30MUS00 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

EMFEMME V tip - B108785TIPVMUS00 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

HPM-6000 - B108799PO121ENUS1000 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

BTL EMSCULPT - B108799PO2166ENUS0100 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : NGX

Prescription Use : Yes

Device Count : 1

BTL EMSCULPT - B108799PO2166ENUS0110 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : NGX

Prescription Use : Yes

Device Count : 1

BTL EMSCULPT - B108799PO2166ENUS0120 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : NGX

Prescription Use : Yes

Device Count : 1

BTL EMSCULPT - B108799PO2166ENUS0130 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : NGX

Prescription Use : Yes

Device Count : 1

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