FDA.reportPublic FDA data

OmniStand

Primary DI
04041925002805
Brand
OmniStand
Company
medica - Medizintechnik GmbH
Model
A000-509
Device description
Exerciser, non-measuring for stroke rehabilitation
Published
2023-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKSExerciser, Non-Measuring For Stroke Rehabilitation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKSExerciser, Non-Measuring For Stroke RehabilitationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04041925002805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04041925002805040419250028054041925002805

GMDN Terms#

Term, Definition table
TermDefinition
Standing balance frameA non-powered, frame-like device intended to help provide hands-free support for a standing patient during rehabilitative standing practice and exercise under clinician supervision. It consists of a standing platform and superstructure frame with a knee support rail against which the knee/lower leg can be placed to prevent the knee giving way. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18003501100acp-customersupport@hanger.com

Regulatory Flags#

DUNS number
328011325
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04041925006339PHS - XSGBS 01.YY.ZZA008-6852026-05-13
04041925006346PHS - SGBS 01.YY.ZZA008-6862026-05-13
04041925006353PHS - MGBS 01.YY.ZZA008-6872026-05-13
04041925006360PHS - LGBS 01.YY.ZZA008-6882026-05-13
04041925006377PHS - XLGBS 01.YY.ZZA008-6892026-05-13
04041925006117PHS - XSGBS 01.YY.ZZA008-6852024-11-14
04041925006124PHS - SGBS 01.YY.ZZA008-6862024-11-14
04041925006131PHS - MGBS 01.YY.ZZA008-6872024-11-14
04041925006148PHS - LGBS 01.YY.ZZA008-6882024-11-14
04041925006155PHS - XLGBS 01.YY.ZZA008-6892024-11-14
04041925006230THERA-Trainer bemo02.YY.ZZA006-8772026-03-16
04041925006247THERA-Trainer bemo02.YY.ZZA006-8782026-03-16
04041925002812THERA-Trainer bemo01.XX.XX2023-10-23
04041925006254THERA-Trainer toro01.05.ZZ2025-12-16
04041925006261THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006278THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006285THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006308OmniCycle® Revo 01.05.ZZ2025-12-16
04041925006315OmniCycle® Revo01.05.ZZ2025-12-16
04041925006193THERA-Trainer toro01.YY.XX2025-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04041925002713THERA-Trainer balomedica - Medizintechnik GmbHPKS2023-10-23
04041925002720THERA-Trainer coromedica - Medizintechnik GmbHPKS2023-10-23
B168EKSOUE0EksoUEEkso Bionics, Inc.PKS2022-03-03