FDA.reportPublic FDA data

Patient Helper

Primary DI
00670482000838
Brand
Patient Helper
Company
Umano Medical Inc
Model
299-0100WG-TRI
Catalog number
299-0100WG-TRI
Device description
A full-body exercise apparatus designed to improve the range of motion around the joints by stretching the major muscle groups in the body using bars.
Published
2024-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10670482000835PackageGS11In Commercial Distribution
00670482000838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067048200083510670482000835
00670482000838006704820008386704820008380670482000838

GMDN Terms#

Term, Definition table
TermDefinition
Trapeze bar exerciserA full-body exercise apparatus designed to improve the range of motion around the joints by stretching the major muscle groups in the body using bars. It may consist of short moveable bars that hang from springs supported by a metal frame installed on a horizontal table, or of trapezoid-like steel bars that hang from chains supported by a metal frame attached to a bed; both assist in stretching exercises of the upper limbs, trunk, and lower limbs, and also help users to change position in bed. The device is mainly intended to improve the flexibility of muscles; it can also increase muscle strength, balance, and coordination, and/or increase cardiovascular endurance.

Regulatory Flags#

DUNS number
249675476
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00670482001019oneNEST M303-M803508HS2FB-BIL2026-04-24
00670482001026oneNEST M303-M843508HS2FB-BIL2026-04-24
00670482001071Echo-Flex 5002903-00002026-02-18
00670482000982Umano Connect282-0002282-00022025-08-04
00670482000920ook snowFL36 ook snowFL362025-05-16
00670482000944ook cocoonFL36 ook cocoonFL362025-05-16
00670482000951ook snow ALL200-0000200-00002025-05-16
10670482000927ook snowFL36 ook snowFL362025-05-16
00670482000937ook snow MHFL36 ook snow MHFL36 ook snow MH2025-05-16
10670482000941ook cocoonFL36 ook cocoonFL362025-05-16
10670482000958ook snow ALL200-0000200-00002025-05-16
00670482000463Freedom 500FM500FM5002021-02-05
00670482000487Freedom 1000FM1000FM10002021-06-04
00670482000470Freedom 1000FM1000FM10002021-02-05
00670482000845REMOVABLE PATIENT CONTROL – 2 FUNCTIONSFA64511-TRIFA64511-TRI2024-09-17
00670482000852REMOVABLE PATIENT CONTROL – 2 FUNCTIONSFA64509-TRIFA64509-TRI2024-09-17
00670482000869REMOVABLE PATIENT CONTROL – 5 FUNCTIONS299-0152-TRI299-0152-TRI2024-09-17
00670482000876REMOVABLE PATIENT CONTROL – 5 FUNCTIONSFA64510-TRIFA64510-TRI2024-09-17
00670482000883REMOVABLE PATIENT CONTROL – 6 FUNCTIONS299-0151-TRI299-0151-TRI2024-09-17
10670482000835Patient Helper 299-0100WG-TRI299-0100WG-TRI2024-09-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977918410143SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNL2026-06-08
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10190676005557POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
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10190676005601POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
07613327584745Sidekick SpraySTRYKER CORPORATIONFNL2022-02-28
10080196313877MedlineMEDLINE INDUSTRIES, INC.FNL2020-11-12
M368GS4054DW1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-06
M368GS3648B1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
M368GS4842B1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
M368GS4842DNS1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
M368GS4842DW1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
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08592654185421Eleganza 3L I N E T spol. s r.o.FNL2018-10-29
08592654186190Eleganza 3L I N E T spol. s r.o.FNL2018-09-18
08592654114766Eleganza 3L I N E T spol. s r.o.FNL2018-04-09