FDA.reportPublic FDA data

AVACEN

Primary DI
00862800000303
Brand
AVACEN
Company
AVACEN MEDICAL, INC
Model
AVACEN HOME
Device description
The AVACEN HOME consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME 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 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.
Published
2017-05-03
Public version status
Update
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
00862800000303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862800000303008628000003038628000003030862800000303

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 normally available [non-prescription] over-the-counter (OTC) for use in the home.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure500 millibar1060 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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862800000341AVACENAVACEN HOME+ 5-YEAR2023-03-10
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
00862800000310AVACENVCI2017-05-03
00862800000327AVACEN100-pack Mitts2017-05-03
00862800000334AVACEN25-pack Mitts2017-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810110200562BeurerBEURER NORTH AMERICA, L.P.IRT2026-06-09
00850087490177AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00850087490184AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00041298995326DMID-M-S HOLDINGS, INC.IRT2026-06-05
00622356691161Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356699631Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356703048Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356704885Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356710664Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00840295411637TherabodyTherabody, Inc.IRT2026-06-01
00041298995043DMID-M-S HOLDINGS, INC.IRT2025-12-30
09413000135374Flowpresso Compression DeviceMEDELLA HEALTH LIMITEDIRT2025-10-16
00041298991960DMID-M-S HOLDINGS, INC.IRT2025-06-12
00031262116291HomedicsHuizhou XINYI Technology Co., LTDIRT2025-02-01
00031262116697HomedicsHuizhou XINYI Technology Co., LTDIRT2025-01-01
00031262116666HomedicsHuizhou XINYI Technology Co., LTDIRT2024-12-31
00031262109507HomedicsHuizhou XINYI Technology Co., LTDIRT2024-11-12
00031262113306HomedicsFKA DISTRIBUTING CO., LLCIRT2024-09-30
00031262115416HomedicsFKA DISTRIBUTING CO., LLCIRT2024-09-30
00031262115379HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115386HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115393HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115423HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115768HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00041298991953DMID-M-S HOLDINGS, INC.IRT2024-02-28
B311PETNHTPR0PURE ENRICHMENTBEAR DOWN CONSULTINGIRT2023-12-15