ACESSA HEALTH INC.

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Device Description : Acessa Pads, disposable dispersive pad, connects to the Acessa ProVu ConsoleLega Acessa Pads, disposable dispersive pad, connects to the Acessa ProVu ConsoleLegacy #854763006010

Device Class : 2

Duns Number: 080935394

Premarket Exempt : No

Product Code : HFG, OEW, IYO, ITX

Prescription Use : No

Device Count : 1

Device Description : Acessa Pad Cable, Reusable, connects to the Acessa ProVu ConsoleLegacy DI #854763006072

Device Class : 2

Duns Number: 080935394

Premarket Exempt : No

Product Code : ITX, OEW, IYO, HFG

Prescription Use : No

Device Count : 1

Device Description : Acessa Table Top Field Generator (TTFG), connects to the Acessa ProVu Console. I Acessa Table Top Field Generator (TTFG), connects to the Acessa ProVu Console. Includes TTFG Pad Set

Device Class : 2

Duns Number: 080935394

Premarket Exempt : No

Product Code : OEW, ITX, IYO, HFG

Prescription Use : No

Device Count : 1

Device Description : Disposable Handpiece connects to Acessa ProVu Console

Device Class : 2

Duns Number: 080935394

Premarket Exempt : No

Product Code : ITX, IYO, OEW, HFG

Prescription Use : No

Device Count : 1

Device Description : Acessa ProVu Handpiece Cable, Reusable, Connects to the Acessa ProVu Console

Device Class : 2

Duns Number: 080935394

Premarket Exempt : No

Product Code : ITX, IYO, OEW, HFG

Prescription Use : No

Device Count : 1

Device Description : Acessa ProVu Transducer with sensor, Reusable, connects to the Acessa ProVu Console

Device Class : 2

Duns Number: 080935394

Premarket Exempt : No

Product Code : IYO, OEW, HFG

Prescription Use : No

Device Count : 1

Device Description : Acessa ProVu Planar Field Generator (PFG), connects to the ProVu Console

Device Class : 2

Duns Number: 080935394

Premarket Exempt : No

Product Code : ITX, IYO, OEW, HFG

Prescription Use : No

Device Count : 1

Device Description : Acessa ProVu System, Power Cord, Foot Pedal Assembly, Video Cable

Device Class : 2

Duns Number: 080935394

Premarket Exempt : No

Product Code : ITX, IYO, OEW, HFG

Prescription Use : No

Device Count : 1

Device Description : Field generator clamp assembly that connects the Planar Field generator to the h Field generator clamp assembly that connects the Planar Field generator to the hospital bed

Device Class : 2

Duns Number: 080935394

Premarket Exempt : No

Product Code : ITX, IYO, OEW, HFG

Prescription Use : No

Device Count : 1

Device Description : Pneumatic foot pedals with tubing used to turn RF energy on and off.

Device Class : 2

Duns Number: 080935394

Premarket Exempt : No

Product Code : HFG

Prescription Use : Yes

Device Count : 1