FDA.reportPublic FDA data

InTandem

Primary DI
00860001790849
Brand
InTandem
Company
Medrhythms, Inc.
Model
001PRF
Device description
InTandem is indicated to improve walking and ambulation in adult chronic stroke patients.
Published
2025-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001790849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001790849008600017908498600017908490860001790849

GMDN Terms#

Term, Definition table
TermDefinition
Physical/neuromuscular rehabilitation softwareA software program intended to help a patient regain functional physical and/or neuromuscular control through guided activities (e.g., physiotherapy exercises, visuomotor stimulating onscreen patterns, interactive games, speech exercises), in cases of musculoskeletal, neurological, and/or oral-motor conditions/events (e.g., trauma, Parkinson’s, stroke, traumatic brain injury). It is intended to be used in the home on a non-medical device (e.g., tablet, smartphone, computer); it is not intended to interface with external biomechanical function analysis equipment. Some types involve clinical supervision or consultation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080565076
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
00860001790856Movive005PRF2025-10-14
00860001790825InTandem Education Unit001EDU2025-06-13
00860001790832Movive Education Unit005EDU2025-06-13
00860001790818Movive00502025-03-10
00860001790801InTandem00102023-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260242060200DIERS iEMGDIERS International GmbHHCC2026-03-09
00852168008004LIFE SystemHARMONIC ENERGETIC TECHHCC2026-03-05
07290019255055SCENTIFIC Respiratory BiofeedbackAPPSCENT MEDICAL LTDHCC2026-02-16
08719481550165NeXus Q24Mind Media Europe B.V.HCC2025-12-03
00860001790856MoviveMedrhythms, Inc.HCC2025-10-14
00860001790825InTandem Education UnitMedrhythms, Inc.HCC2025-06-13
00860001790832Movive Education UnitMedrhythms, Inc.HCC2025-06-13
10885380198786KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198878KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198885KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198892KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198908KangarooCardinal Health 200, LLCHCC2025-03-12
10885380200199KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198793KangarooCardinal Health 200, LLCHCC2025-03-12
00860001790818MoviveMedrhythms, Inc.HCC2025-03-10
B185FS059370FST5Freespira, Inc.HCC2025-01-23
09413000107500AxonEXSURGO LIMITEDHCC2025-01-15
07540191000647BioGraph Infiniti Advanced ReportingThought Technology Ltd.HCC2024-12-12
00855846007245MyoPro 2x Assembly KitMyomo, Inc.HCC2024-12-11
00855846007252MyoPro 2x Assembly KitMyomo, Inc.HCC2024-12-11
00855846007238Mobile Arm Rehabilitation Kit version 2 (MARK2)Myomo, Inc.HCC2024-10-11
00855846007191Mobile Arm Rehabilitation Kit version 2 (MARK2)Myomo, Inc.HCC2024-10-11
00855846007214MyoPro 2xMyomo, Inc.HCC2024-09-20
00855846007221MyoPro 2xMyomo, Inc.HCC2024-09-20
00855846007177MyoPro 2xMyomo, Inc.HCC2024-09-20
00855846007184MyoPro 2xMyomo, Inc.HCC2024-09-20
00092237626573Richmar EMG SoftwareCOMPASS HEALTH BRANDS CORP.HCC2024-06-28
00851679007360Trigno Avanti SensorDELSYS, INC.HCC2024-05-06
00851679007377Trigno CentroDELSYS, INC.HCC2024-05-06
00851679007384Trigno Charge-16DELSYS, INC.HCC2024-05-06