FDA.reportPublic FDA data

RL-500

Primary DI
08809315679817
Brand
RL-500
Company
DAESUNG MAREF CO.,LTD.
Model
1000860
Device description
Hose 1ea, Com cable 1ea (1 set box)
Published
2021-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809315679814PackageGS110In Commercial Distribution
28809315679811PackageGS140In Commercial Distribution
08809315679817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880931567981418809315679814
2880931567981128809315679811
08809315679817088093156798178809315679817

GMDN Terms#

Term, Definition table
TermDefinition
Hand/wrist continuous passive motion exerciserA mains electricity (AC-powered) device designed to continuously move the metacarpal/interphalangeal joints (e.g., flexion and extension) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joints. It typically consists of a motorized carriage with straps to hold and move the hand/wrist, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; digital displays, manual/automated safety capabilities, and other features may also be included. CPM is believed to stimulate articular tissues and circulation of synovial fluid, and to reduce joint oedema.

Regulatory Flags#

DUNS number
688817949
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809802648494DVT-SERIESDS0312026-02-09
08809802648500DVT-SERIESDS0332026-02-09
18809802648491DVT-SERIESDS0312026-02-09
18809802648507DVT-SERIESDS0332026-02-09
08809802645301SP-1000SP10100-LL2025-12-19
08809802645318SP-1000SP10100-LX2025-12-19
08809802645325SP-1000SP10100-LZ2025-12-19
08809802645462SP-2000SP20100-LL2025-12-19
08809802645479SP-2000SP20100-LX2025-12-19
08809802645486SP-2000SP20100-LZ2025-12-19
08809802646131LX9maxLX9M100-LL2025-12-19
08809802646148LX9maxLX9M100-LX2025-12-19
08809802646155LX9maxLX9M100-LZ2025-12-19
08809802646810DVT-2600DVT3120-DT2025-12-19
08809802646858DVT-4000SDVT4100-DT2025-12-19
08809802645295SP-1000SP101002025-12-19
18809802645308SP-1000SP10100-LL2025-12-19
18809802645315SP-1000SP10100-LX2025-12-19
18809802645322SP-1000SP10100-LZ2025-12-19
08809802645332SP-1000SP10100-RL2025-12-19

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Primary DI, Brand, Company table
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04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
06976287180787Active Passive Trainer for Upper and Lower LimbsGuangzhou Longest Medical Technology Co., Ltd.BXB2026-04-14
00888912267588CHATTANOOGADJO, LLCBXB2026-03-31
00888912267618CHATTANOOGADJO, LLCBXB2026-03-31
00888912267625CHATTANOOGADJO, LLCBXB2026-03-31
00888912267632CHATTANOOGADJO, LLCBXB2026-03-31
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