FDA.reportPublic FDA data

AVACEN

Primary DI
00862800000341
Brand
AVACEN
Company
AVACEN MEDICAL, INC
Model
AVACEN HOME+ 5-YEAR
Device description
The AVACEN HOME+ consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. TheAVACEN HOME+ 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+ for approximately 10 to 30 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
00862800000341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862800000341008628000003418628000003410862800000341

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
00862800000372AVACENAVACEN HOME XL 3-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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