FDA.reportPublic FDA data

AECORMax Body

Primary DI
00850001456418
Brand
AECORMax Body
Company
Omm Imports Inc.
Model
AEMAX
Published
2022-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001456418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001456418008500014564188500014564180850001456418

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010000704
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001456784MODEL S+ BY SPIRULUX S9002026-05-03
00850001456791PRO MED BY JOUVALLE J9002026-05-02
00850001456746Quantum Q12026-03-02
00850001456739Elevare ONEE900 2025-12-01
00850001456357RelaxatioRX1002022-06-30
00850001456548Perfectio X G2G2-PX2024-10-28
00850001456524Genesis PrimeGP1002024-08-28
00850001456531GlorificoGL222024-08-28
00850001456555Glorifico PlusGL22+2024-08-28
00850001456647Genesis SkyeGSKYE2024-08-28
00850001456678ElevareE8002024-08-28
00850001456685Elevare PlusE7502024-08-28
00850001456692Elevare IvoryE5002024-08-28
00850001456708RevvE550R2024-08-28
00850001456715SpiruluxSP8002024-08-28
00850001456456Genesis ZGZ1002022-07-29
00850001456036Perfectio XPX1002022-06-30
00850001456067RecreoR2002022-06-30
00850001456111Juvenis J700B-S2022-06-30
00850001456128JuvenisJ700B-B2022-06-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831431Human TouchHuman Touch, LLCISA2026-01-12
00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
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