rebless

Basic Information

• Brand Name: rebless
• Primary DI: 08800101600060
• Version / Model: RHSW
• Company Name: H ROBOTICS INC.
• Labeler DUNS: 695126303
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-18
• Public Version: 2
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: f934b9c8-1db7-4ee6-90a5-9a37f6db8d4b

Device Description

adapter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BXB	Exerciser, Powered	Physical Medicine	890.5380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete
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.	No	Obsolete
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800101600060	GS1