FDA.reportPublic FDA data

PHTSIOGAIT US

Primary DI
05903684803286
Brand
PHTSIOGAIT US
Company
MEDEN INMED SP Z O O
Model
non-AC-powerd
Catalog number
01-ELV-0105-001
Device description
PhysioGait Dynamic Partial Weight Bearing system is intended to accomplish dynamic patient support used in the rehabilitation and gait reeducation. The device is used for therapeutic and diagnostic purposes (training balance and gait). It is ideal for working with neurological and orthopedic patients, both adults and children.
Published
2022-11-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05903684803286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903684803286059036848032865903684803286

GMDN Terms#

Term, Definition table
TermDefinition
Fixed patient lifting system, manualA non-powered, fixed assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort within an area limited by the lifting radius of the system. Also known as a patient hoist, it typically consists of a support base fixed permanently to a ceiling, wall, floor, or piece of equipment such as a bath or the edge of a swimming pool, with a lifting mechanism, mast, boom/lifting arm(s), swivel bar, and patient holding device (e.g., a sling, holder or a frame). The lifting mechanism provides mechanical advantage (e.g., using pneumatic springs) to aid manual movement of components.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth135Centimeter
Height210Centimeter
Height234Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
367142903
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05903684801671MONTANE ATLAS M-S3.F4 [SZER 69 CM]01-STO-3007-00135362022-11-04
05903684802074MONTANE ALPS M-P5.F4 [SZER 69 CM]01-STO-3023-00133582022-11-04
05903684801428MONTANE TATRAS M-S2.F0 [SZER 69 CM]01-STO-3002-00435202022-11-03
05903684801459MONTANE TATRAS M-S2.F4 [SZER 69 CM]01-STO-3003-00135232022-11-03
05903684801619MONTANE ATLAS M-S3.F0 [SZER. 69 CM]01-STO-3006-00135352022-11-03
05903684801251GALAXY TRACTION T3.F0 [SZER 70 CM] XL01-STO-3407-00532632023-11-15
05903684801299GALAXY TRACTION T3.F4 XL [SZER 70 CM]01-STO-3408-00532642023-11-15
05903684801381GALAXY TRACTION T4.F4 XL [SZER 70 CM] 01-STO-3424-00532672023-11-15
05903684803248TRITON 6 E (SZER. 69) 01-STO-3620-0024769E2023-11-06
05903684802319MONTANE ANDES M-P7.F4 [SZER 76 CM]01-STO-3025-0053573XL2023-09-25
05903684802142TRITON 6 E (SZER. 70) 01-STO-3620-0014769E2022-11-07
05903684803231TRITON 6 M (SZER. 70) 01-STO-3610-0024769M2022-11-07
05903684800315MONTANE TATRAS GERLACH E-S2.F4 [SZER. 69 CM]01-STO-3031-00135252022-11-04
05903684801756MONTANE ATLAS M-P3.F0 [SZER 69 CM]01-STO-3020-00435372022-11-04
05903684801787MONTANE ATLAS M-P3.F0 [SZER 69 CM] US01-STO-3020-00435322022-11-04
05903684801817MONTANE ATLAS M-P3.F4 [SZER 69 CM]01-STO-3021-001313622022-11-04
05903684801848MONTANE ATLAS M-P3.F4 [SZER 69 CM] US01-STO-3021-00435332022-11-04
05903684801879MONTANE ALPS M-S5.F0 [SZER. 69] 01-STO-3008-00135552022-11-04
05903684801909MONTANE ALPS M-S5.F0 [SZER. 69 CM] US01-STO-3008-00435502022-11-04
05903684801930MONTANE ALPS M-S5.F4 [SZER 69 CM] 01-STO-3009-00135562022-11-04

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Primary DI, Brand, Company table
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