AccessGUDID - DEVICE: rebless (08800101600015)

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GUDID

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Device Identifier (DI) Information

Brand Name: rebless
Version or Model: RHSW
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: H ROBOTICS INC.

Primary DI Number: 08800101600015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695126303 *Terms of Use

Device Description: No description.

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Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38064	Ankle continuous passive motion exerciser	A mains electricity (AC-powered) device designed to continuously move the ankle joint (e.g., flexion, inversion/eversion) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint. The device typically consists of a motorized carriage with straps to hold and move the leg/ankle, 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.	Obsolete	false
17137	Hand/wrist continuous passive motion exerciser	A 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.	Obsolete	false
36313	Continuous passive motion joint exerciser	A mains electricity (AC-powered) device designed to continuously move one or more joints (shoulder, elbow, wrist, hand/fingers, hip, knee, ankle, and/or feet/toes) without patient assistance during continuous passive motion (CPM) exercise therapy. It typically consists of a motorized carriage with pads and straps to hold and support the limb/digit, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; it may additionally be intended to provide active resistance. It is typically intended to stimulate articular tissues, circulation of synovial fluid, reduce joint oedema, and provide neuromuscular and/or coordination training.	Active	false

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FDA Product Code

Product Code	Product Code Name
BXB	Exerciser, Powered

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FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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Storage and Handling

Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius

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Clinically Relevant Size

Size Type Text
No Device Sizes

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Device Record Status

Public Device Record Key: 6f273cea-bee1-4a50-9bf9-c6086e0edad6
Public Version Date: June 19, 2023
Public Version Number: 2
DI Record Publish Date: March 16, 2021

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Alternative and Additional Identifiers Additional Identifiers

Package DI

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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Secondary DI

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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Unit of Use DI

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
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Production Identifier(s) in UDI

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

Phone: +821071599649
Email: danbi.lee@hrobotics-rehab.com

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