AVACEN
GUDID 00862800000372
The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL 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 HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system Electric pad localized-body heating system| Primary Device ID | 00862800000372 |
| NIH Device Record Key | 7a45571f-fc1e-42a2-8945-9c09dc1f2f96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AVACEN |
| Version Model Number | AVACEN HOME XL 3-YEAR |
| Company DUNS | 832744754 |
| Company Name | AVACEN MEDICAL, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com | |
| Phone | 888-428-2236 |
| support@avacen.com |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862800000372 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133981
FDA Product Code
| IRT | Pad, Heating, Powered |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-20 |
| Device Publish Date | 2023-03-10 |
On-Brand Devices [AVACEN]
| 00862800000334 | 25-pack Mitts |
| 00862800000327 | 100-pack Mitts |
| 00862800000310 | Vacuum Chamber Insert (VCI) |
| 00862800000303 | The AVACEN 100 consists of a control panel, temperature-controlled raised thermal transfer pad, |
| 00862800000358 | The AVACEN PRO consists of a control panel, temperature-controlled raised thermal transfer pad, |
| 00862800000365 | The AVACEN PRO+ consists of a control panel, temperature controlled raised thermal transfer pad, |
| 00862800000396 | The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer p |
| 00862800000389 | The POP-ON/POP-OFF cuff is for replacement part on Gen 3 AVACEN products (HOME XL and PRO+). |
| 00862800000372 | The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer p |
| 00862800000341 | The 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 90606711 not registered Live/Pending |
Avacen 2021-03-26 |
 AVACEN 85333252 4083448 Dead/Cancelled |
AVACEN, INC. 2011-05-29 |
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