FDA.reportPublic FDA data

NUSHU

Primary DI
07649998859035
Brand
NUSHU
Company
Magnes AG
Model
1
Device description
NUSHU iOS Mobile Application
Published
2026-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JFCSystem, Pressure Measurement, Intermittent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFCSystem, Pressure Measurement, IntermittentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649998859035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649998859035076499988590357649998859035

GMDN Terms#

Term, Definition table
TermDefinition
Motor-impairment therapeutic wearable vibratory stimulatorA noninvasive device designed to be worn by a patient to help reduce chronic and debilitating motor impairments (e.g., tremors, stiffness, slowness) through application of continuous or intermittent gentle vibrotactile somatosensory stimulation (cueing and focused stimulation) to the body surface. It is in the form of a battery-powered, button-like device adhered to the skin, typically on the chest, and may wirelessly connect to a smartphone for control of stimulation settings and to facilitate tracking of impaired motor symptoms.

Regulatory Flags#

DUNS number
480046149
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07649998859011NUSHU12026-05-31
07649998859028NUSHU12026-05-31
07649998859059NUSHU12026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649998859011NUSHUMagnes AGJFC2026-05-31
07649998859028NUSHUMagnes AGJFC2026-05-31
04260242060217DIERS pedoscanDIERS International GmbHJFC2026-03-09
05425026002008Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002015Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002046Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002053Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05391550080006Danu DANU SPORTS LIMITEDJFC2025-12-17
06941691920540Orantech Orantech Inc.JFC2024-12-17
06941691921134Orantech Orantech Inc.JFC2024-12-17
06941691909620Orantech Orantech Inc.JFC2024-12-05
06941691909736Orantech Orantech Inc.JFC2024-12-05
06941691910022Orantech Orantech Inc.JFC2024-12-05
06941691910619Orantech Orantech Inc.JFC2024-12-05
06941691910688Orantech Orantech Inc.JFC2024-12-05
06941691911425Orantech Orantech Inc.JFC2024-12-05
03760349820055FeetMe Monitor FTM-DKFEETMEJFC2023-03-24
07540150603308BodiTrakVista Medical LtdJFC2022-12-13
07540150603780BodiTrakVista Medical LtdJFC2022-12-13
03760349820048FeetMe Monitor FTM-DKFEETMEJFC2022-11-11
B970303012503030-125 SensorTekscan, Inc.JFC2020-11-04
B9703000E12503000-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000E5003000-E-50 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000ES03000-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTE12503000SPORT-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTE5003000SPORT-E-50 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTES03000SPORT-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703001E12503001-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703001ES03001-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703001SPORTE12503001SPORT-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03