FDA.reportPublic FDA data

PERFORMANCE HEALTH

Primary DI
00840216112469
Brand
PERFORMANCE HEALTH
Company
Asp Global, LLC
Model
A873620
Device description
Rolyan Reach’N Range Overhead Pulley
Published
2022-08-09
Public version status
New
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
00840216112469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216112469008402161124698402161124690840216112469

GMDN Terms#

Term, Definition table
TermDefinition
Upper-limb mechanical weight exerciser, lever/pulley-cableA mechanical exercise apparatus intended primarily to strengthen the major muscles of the upper limb (e.g., biceps, triceps, deltoids, brachioradialis, wrist flexors and extensors) through a repetitive pushing, pulling, curling, or extending motion performed with the arms/hands against the force of a weight. It typically consists of a metal frame containing a lever or pulley-cable system that incorporates changeable weights and bars and/or handles/hand stirrups for the hands and arms; a bench may be included for the user to sit or lay while performing the exercise. The device may also be used to improve upper limb flexibility and mobility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080361159
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216128774ASP Global / PrimoCF120B2026-09-04
00840216103696ASP MEDICALMRT1322022-08-23
00840216127869Northside HospitalNSAMK-052026-07-23
00840216129290Quest DiagnosticsQD11X16KPAP2026-07-17
00840216129801LabCorpLC13X22BIO2026-07-17
00840216108738ASP MEDICALFMT630V2020-10-21
00840216108943ASP MEDICALFMT7002020-10-21
00840216108967ASP MEDICALFMT7102020-10-21
00840216108974ASP MEDICALFMT6552020-10-21
00840216108998ASP MEDICALFMT645V2020-10-21
00840216109018ASP MEDICALFMT640V2020-10-21
00840216109025ASP MEDICALFMT635V2020-10-21
00840216110922ASP MEDICALFMT605HEART2022-02-09
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120077180311Elvistyromotion GmbHION2026-08-03
08054040401879BIKOORMESA SRLION2026-08-01
08054040401886BIKOORMESA SRLION2026-08-01
08054040401893BIKOORMESA SRLION2026-08-01
08054040401909BIKOORMESA SRLION2026-08-01
08054040401916BIKOORMESA SRLION2026-08-01
08054040401923BIKOORMESA SRLION2026-08-01
08054040401930BIKOORMESA SRLION2026-08-01
08054040401947BIKOORMESA SRLION2026-08-01
08054040401954BIKOORMESA SRLION2026-08-01
08054040401961BIKOORMESA SRLION2026-08-01
08054040401978BIKOORMESA SRLION2026-08-01
08054040401985BIKOORMESA SRLION2026-08-01
08054040401992BIKOORMESA SRLION2026-08-01
08054040402005BIKOORMESA SRLION2026-08-01
08054040402876BIKOORMESA SRLION2026-08-01
08054040403729BIKOORMESA SRLION2026-08-01
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