FDA.reportPublic FDA data

AVACEN

Primary DI
00862800000372
Brand
AVACEN
Company
AVACEN MEDICAL, INC
Model
AVACEN HOME XL 3-YEAR
Device description
The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. TheAVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches andpains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pumpcreates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
Published
2023-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133981000AVACEN 100Avacen, Inc.2014-08-15IRT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862800000372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862800000372008628000003728628000003720862800000372

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure500 millibar1600 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-428-2236support@avacen.com

Regulatory Flags#

DUNS number
832744754
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862800000341AVACENAVACEN HOME+ 5-YEAR2023-03-10
00862800000389AVACENPOP-ON/POP-OFF CUFF2023-03-10
00862800000396AVACENAVACEN HOME XL 5-YEAR2023-03-10
00862800000365AVACENHOME XL2022-10-28
00862800000358AVACENAVACEN HOME+2019-12-31
00862800000303AVACENAVACEN HOME2017-05-03
00862800000310AVACENVCI2017-05-03
00862800000327AVACEN100-pack Mitts2017-05-03
00862800000334AVACEN25-pack Mitts2017-07-19

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