FDA.report

rebless planar

Primary DI
08800101600169
Brand
rebless planar
Company
H ROBOTICS INC.
Model
RPLSW
Device description
rebless planar is a robotic-assisted upper extremity rehabilitation device that improves motor skills, range of moion, and strength, improving patients overall functional ability.
Published
2023-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IKKSystem, Isokinetic Testing And Evaluation

Product Code Classifications

CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800101600169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800101600169088001016001698800101600169

GMDN Terms

TermDefinition
Virtual-display rehabilitation system, powered-support, upper-limbAn assembly of devices intended to be used in a clinical setting to provide gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the upper limbs (e.g., impaired arm function) through patient interaction with a videogame-like display prompting repeated motion of the limb under treatment (e.g., arm, hand, wrist, shoulder) for functional improvement (e.g., reaching, grasping); it may also provide performance feedback and manual/automatic setting adjustments. It consists of a limb support capable of actively assisting the patient’s movements (e.g., powered robotic arm), and a computer/monitor with software.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal101.3 KiloPascal
Handling Environment Humidity35 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity35 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
695126303
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800101600183rebless (Model: RHDB)RHDB12023-10-30
08800101600039reblessRHSW2021-03-18
08800101600046reblessRHSW2021-03-18
08800101600053reblessRHSW2021-03-18
08800101600060reblessRHSW2021-03-18
08800101600077reblessRHSW2021-03-18
08800101600084reblessRHSW2021-03-18
08800101600091reblessRHSW2021-03-18
08800101600107reblessRHSW2021-03-18
08800101600015reblessRHSW2021-03-16
08800101600022reblessRHSW2021-03-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B108660POMUS00R-GAITBTL INDUSTRIES LIMITEDIKK2026-03-19
09120077180250LEXOtyromotion GmbHIKK2026-03-12
06979351820015Upper Limb Rehabilitation Training SystemShanghai ZDROID Medical Technology Co.,Ltd.IKK2025-12-23
05061081950009LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03
05061081950184LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03
00810188050021Bioness Integrated System (BITS) Bedside ConfigurationBioness Medical, Inc.IKK2025-07-18
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.IKK2025-07-18
00810188050038Bioness Integrated System (BITS) Mobile ConfigurationBioness Medical, Inc.IKK2025-07-17
08809209591980InBodyInBody Co., Ltd.IKK2025-05-09
00860013061104ReflexAssistive Technology Development, Inc.IKK2025-04-23
04041925006117PHS - XSmedica - Medizintechnik GmbHIKK2024-11-14
04041925006124PHS - Smedica - Medizintechnik GmbHIKK2024-11-14
04041925006131PHS - Mmedica - Medizintechnik GmbHIKK2024-11-14
04041925006148PHS - Lmedica - Medizintechnik GmbHIKK2024-11-14
04041925006155PHS - XLmedica - Medizintechnik GmbHIKK2024-11-14
00860002828749PortableConnectRom Technologies, Inc.IKK2024-03-20
00628719321003Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321010Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321027Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321034Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321041Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321058Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321065Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321072Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00840216113978PRIMOAsp Global, LLCIKK2023-11-15
08800101600183rebless (Model: RHDB)H ROBOTICS INC.IKK2023-10-30
04041925002775THERA-Trainer lyramedica - Medizintechnik GmbHIKK2023-10-23
07640174660353ArmeoHOCOMA AGIKK2023-10-11
07640174660377ManovoHOCOMA AGIKK2023-10-11
07640174660391ArmeoHOCOMA AGIKK2023-10-11