FDA.reportPublic FDA data

ReJoyce

Primary DI
17540176010033
Brand
ReJoyce
Company
Rehabtronics Inc
Model
RV10
Device description
The ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities.
Published
2019-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IONExerciser, Non-Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540176010033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1754017601003317540176010033

GMDN Terms#

Term, Definition table
TermDefinition
Virtual-display rehabilitation system, passive-supportAn assembly of devices intended to be used in a clinical setting to provide gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the upper limbs (e.g., impaired arm function) through patient interaction with a videogame-like display prompting repeated motion of the limb under treatment (e.g., arm, hand, wrist, shoulder) for functional improvement (e.g., reaching, grasping); it may also provide performance feedback. It consists of a non-powered weight support (e.g., suspension sling, armrest) whereby the patient’s movements are detected by and presented on a dedicated computer/monitor with software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243936569
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
17540176050091PreliviaPR-IES1A2024-11-12
17540176050107Prelivia ElectrodePR-EL1APR-IES1A2024-11-12
17540176050114Prelivia ElectrodePR-EL1AbPR-IES1A2024-11-12
17540176030147ReGraspHSEPKV22024-02-23
17540176030154ReGraspHSEPKBC2024-02-23
17540176030161ReGraspEPKL-S2024-02-23
17540176030178ReGraspEPKL-M2024-02-23
17540176030185ReGraspEPKL-L2024-02-23
17540176030192ReGraspEPKTS2024-02-23
17540176030208ReGraspEPKPN2024-02-23
17540176030215ReGraspEPKGE-L2024-02-23
17540176030222ReGraspEPKGE-S2024-02-23
17540176030239ReGraspEPKCE-L2024-02-23
17540176030246ReGraspEPKCE-S2024-02-23
17540176030253ReGraspHSEP22024-02-23
17540176050039Prelivia LeadsPR-LEAD1PR-LEAD12021-10-04
17540176050046Prelivia Lead BulkPR-LEAD1BPR-LEAD1B2021-10-04
17540176050008PreliviaPR-IES12021-10-01
17540176050022Prelivia ElectrodesPR-IES1PR-IES12021-10-01
17540176030123ReGraspHSEPK12020-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851232007738OxyBREATH NON-MEASURING EXERCISERD R BURTON HEALTHCARE, LLCION2026-04-28
00851232007745OxyTrainer ADVANTAGED R BURTON HEALTHCARE, LLCION2026-04-28
08018294018009AirFeel IMTFLAEM NUOVA SPAION2026-02-18
18018294018006AirFeel IMTFLAEM NUOVA SPAION2026-02-18
00860014768620MouthflexINNOMOTIVE L.L.CION2026-02-11
08054040402029FRAME RUNNERORMESA SRLION2025-10-15
08054040402036FRAME RUNNERORMESA SRLION2025-10-15
08054040401275FRAME RUNNERORMESA SRLION2025-09-20
08054040401282FRAME RUNNERORMESA SRLION2025-09-20
08054040401299FRAME RUNNERORMESA SRLION2025-09-20
08054040401305FRAME RUNNERORMESA SRLION2025-09-20
08054040401312FRAME RUNNERORMESA SRLION2025-09-20
08054040401329FRAME RUNNERORMESA SRLION2025-09-20
08054040401336FRAME RUNNERORMESA SRLION2025-09-20
08054040401343FRAME RUNNERORMESA SRLION2025-09-20
08054040401350FRAME RUNNERORMESA SRLION2025-09-20
08054040401367FRAME RUNNERORMESA SRLION2025-09-20
08054040401374FRAME RUNNERORMESA SRLION2025-09-20
08054040401381FRAME RUNNERORMESA SRLION2025-09-20
08054040401398FRAME RUNNERORMESA SRLION2025-09-20
08054040401404FRAME RUNNERORMESA SRLION2025-09-20
08054040401411FRAME RUNNERORMESA SRLION2025-09-20
08054040401428FRAME RUNNERORMESA SRLION2025-09-20
08054040401435FRAME RUNNERORMESA SRLION2025-09-20
08054040401442FRAME RUNNERORMESA SRLION2025-09-20
00384703160019EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00384703150010EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00384703155015EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00810188050557Vector BaseBioness Medical, Inc.ION2025-07-18
00616784050010Pedal Exerciser, Non-Folding, Hands/FeetDynarex CorporationION2025-05-29