AVACEN

GUDID 00862800000358

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.

AVACEN MEDICAL, INC

Electric pad localized-body heating system
Primary Device ID00862800000358
NIH Device Record Key7e92ae63-949e-42c4-bc07-7be54efd2125
Commercial Distribution StatusIn Commercial Distribution
Brand NameAVACEN
Version Model NumberAVACEN PRO
Company DUNS832744754
Company NameAVACEN MEDICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com
Phone888-428-2236
Emailsupport@avacen.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS100862800000358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IRTPad, Heating, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-08
Device Publish Date2019-12-31

On-Brand Devices [AVACEN]

0086280000033425-pack Mitts
00862800000327100-pack Mitts
00862800000310Vacuum Chamber Insert (VCI)
00862800000303The AVACEN 100 consists of a control panel, temperature-controlled raised thermal transfer pad,
00862800000358The AVACEN PRO consists of a control panel, temperature-controlled raised thermal transfer pad,
00862800000365The AVACEN PRO+ consists of a control panel, temperature controlled raised thermal transfer pad,
00862800000396The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer p
00862800000389The POP-ON/POP-OFF cuff is for replacement part on Gen 3 AVACEN products (HOME XL and PRO+).
00862800000372The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer p
00862800000341The AVACEN HOME+ consists of a control panel, temperature controlled raised thermal transfer pad

Trademark Results [AVACEN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AVACEN
AVACEN
90606711 not registered Live/Pending
Avacen
2021-03-26
AVACEN
AVACEN
85333252 4083448 Dead/Cancelled
AVACEN, INC.
2011-05-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.