FDA.reportPublic FDA data

DigiTrainer

Primary DI
04260397621110
Brand
DigiTrainer
Company
HASOMED GmbH
Model
DigiTrainer
Catalog number
Hand0100
Device description
Exerciser, Finger, Powered
Published
2020-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JFAExerciser, Finger, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFAExerciser, Finger, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260397621110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260397621110042603976211104260397621110

GMDN Terms#

Term, Definition table
TermDefinition
Large-area electric massagerAn electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341439008
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260397621127DigiTrainer SDigiTrainer SHand01012020-06-01
04260397620168RehaStim 2 / RehaMove 2FES00005FES000052016-09-13
04260397620960RehaCom Cognitive Therapy Panel, RehaCom KeyboardReha0099Reha00992016-10-26
04260397620410RehaStim2FES01092FES010922020-11-22
04260397620427RehaStim 2 for HocomaFES01050FES010502020-11-22
04260397620670RehaStim 2FES01050FES010502018-06-05
04260397620342RehaStim 2FES01090FES010902017-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04897148250017HandTaskerHopebotics LimitedJFA2025-07-28
03760272650088Izar™NeuroXtherapeutics SAJFA2023-01-23
B770VEC0Vector 1LANTZ MEDICAL, INC.JFA2022-12-08
04260397621127DigiTrainer SHASOMED GmbHJFA2020-06-01