FDA.reportPublic FDA data

Erigo

Primary DI
07629999033894
Brand
Erigo
Company
HOCOMA AG
Model
Pro
Catalog number
29673
Published
2016-03-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered
GZIStimulator, Neuromuscular, External Functional
INQTable, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1
GZIStimulator, Neuromuscular, External FunctionalNeurology2
INQTable, PoweredPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132416000REHASTIM 2, ERIGOPRO (FES)Hasomed GmbH2014-05-28GZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07629999033894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07629999033894076299990338947629999033894

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy table, line-poweredA mains electricity (AC-powered) device designed for use in physical therapies for mobilization and rehabilitation of neurologically impaired and bedridden patients. It has powered adjustable table functions for height, position and vertical tilting from supine to upright, and typically incorporates foot supports, straps and exercisers (e.g., pulleys or rotators, arm slings, and leg exercisers). It is used during therapeutic exercises and massage typically to enhance blood circulation to the lower limbs in patients with neurological disorders (e.g., spinal cord injury, traumatic brain injury, stroke) and also to aid in muscle training and sense of balance.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
487876203
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640174660353ArmeoSpring Pro619582023-10-11
07640174660377ManovoSpring295682023-10-11
07640174660391ArmeoSupport Harness626442023-10-11
07640174660452LokomatPro 6.3 PE630572023-03-23
07640174660469LokomatPro 6.3 Kombi Motivation630582023-03-23
07640174660476LokomatPro 6.3 AD Motivation630592023-03-23
07640174660483LokomatPro 6.3 PE Motivation630602023-03-23
07640174660490LokomatNanos 1.3630612023-03-23
07640174660407LokomatPro 6.3 FD Kombi630522023-03-22
07640174660414LokomatPro 6.3 FD AD630532023-03-22
07640174660421LokomatPro 6.3 FD PE630542023-03-22
07640174660438LokomatPro 6.3 Kombi630552023-03-22
07640174660445LokomatPro 6.3 AD630562023-03-22
07640174660001ArmeoSpring264052016-08-22
07640174660018ArmeoSpring Pediatric273262016-08-22
07640174660032ErigoBasic295642016-08-22
07640174660056ErigoBasic296722016-08-22
07640174660063LokomatPro300002016-08-22
07640174660070LokomatPro300012016-08-22
07640174660087LokomatPro300022016-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854798000793Torque TablePIVOTAL HEALTH SOLUTIONS, INC.INQ2026-05-27
00815235022631UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022655UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022662UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022679UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022686UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022693UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022709UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022716UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022723UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022730UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022747UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022754UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022761UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022778UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022785UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022792UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022808UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022815UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022822UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022839UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022846UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022853UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022860UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022877UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022884UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022891UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022907UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022914UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022921UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14