Humero Tech

Basic Information

• Brand Name: Humero Tech
• Primary DI: 00860010519905
• Version / Model: C1
• Catalog Number: A1-0000
• Company Name: Titin Km Biomedical Corp.
• Labeler DUNS: 111275045
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-31
• Public Version: 2
• Public Version Date: 2024-02-14
• Public Version Status: Update
• Public Device Record Key: c050fae6-fa3d-441b-a687-db05d286b651

Device Description

The Humero Tech C1 has been developed as a solution for the current limitations with shoulder rehabilitation. The C1 is a seated apparatus capable of completing a vast number of shoulder rehabilitation and strengthening exercises. This device has the capability to be utilized in low level rehabilitation and strengthening progressing to more functional and dynamic activities. The Humero Tech C1 has an intended use of assisting with improving the strength, active range of motion, and motor control of the shoulder complex. Furthermore, the indications for use will be any individual suffering from a shoulder pathology, including postoperative status, or when a deficit in power is noted. The device collects data and tracks range of motion to evaluate progress over time.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
48147	Virtual-display rehabilitation system, passive-support	An 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. It consists of a non-powered weight support (e.g., suspension sling, armrest) whereby the patient’s movements are detected by and presented on a dedicated computer/monitor with software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010519905	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]