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Humero Tech

FDA UDI

Class I (US FDA UDI)

by Titin Km Biomedical Corp.

Identity

Trade Name
Humero Tech FDA UDI
Generic Name
Virtual-display rehabilitation system, passive-support, upper-limb FDA UDI
Device Name
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. FDA UDI
Model / Reference
C1 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
A1-0000 FDA UDI
Primary DI / UDI-DI
00860010519905 FDA UDI
FDA Product Code
BXB FDA UDI
GMDN Term
Virtual-display rehabilitation system, passive-support, upper-limb FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5380 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Virtual-display rehabilitation system, passive-support, upper-limb

Humero Tech by Titin Km Biomedical Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Virtual-display rehabilitation system, passive-support, upper-limb.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Titin Km Biomedical Corp.

Sources (1)

  • FDA UDI c050fae6-fa3d-441b-a687-db05d286b651 35 fields · synced Jun 6, 2026