AVACEN MEDICAL, INC

Address:2365 Camino Vida Roble,Carlsbad,CA,92011,US

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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

Pad, Heating, Powered (IRT) (5)

Premarket Exempt

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AVACEN - 00862800000303 Catalog Number :

Device Description : The AVACEN 100 consists of a control panel, temperature-controlled raised therma The AVACEN 100 consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN 100 is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN 100 for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.

Device Class : 2

Duns Number: 832744754

Premarket Exempt : No

Product Code : IRT

Prescription Use : No

Device Count : 1

AVACEN - 00862800000310 Catalog Number :

Device Description : Vacuum Chamber Insert (VCI)

Device Class : 2

Duns Number: 832744754

Premarket Exempt : No

Product Code : IRT

Prescription Use : No

Device Count : 1

AVACEN - 00862800000327 Catalog Number :

Device Description : 100-pack Mitts

Device Class : 2

Duns Number: 832744754

Premarket Exempt : No

Product Code : IRT

Prescription Use : No

Device Count : 1

AVACEN - 00862800000334 Catalog Number :

Device Description : 25-pack Mitts

Device Class : 2

Duns Number: 832744754

Premarket Exempt : No

Product Code : IRT

Prescription Use : No

Device Count : 1

AVACEN - 00862800000358 Catalog Number :

Device Description : The AVACEN PRO consists of a control panel, temperature-controlled raised therma The AVACEN PRO consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN PRO is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN PRO for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.

Device Class : 2

Duns Number: 832744754

Premarket Exempt : No

Product Code : IRT

Prescription Use : No

Device Count : 1

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