Humero Tech

Primary DI
00860010519905
Brand
Humero Tech
Company
Titin Km Biomedical Corp.
Model
C1
Catalog number
A1-0000
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.
Published
2024-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010519905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010519905008600105199058600105199050860010519905

GMDN Terms#

Term, Definition table
TermDefinition
Virtual-display rehabilitation system, passive-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. 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.

Contacts#

Phone, Email table
PhoneEmail
406-404-6333qara@titinkmbiomedical.com

Regulatory Flags#

DUNS number
111275045
Device count
1
DM exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010519912Humero TechC1 HDA2-00002024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04560340091749Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091756Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
06976287180787Active Passive Trainer for Upper and Lower LimbsGuangzhou Longest Medical Technology Co., Ltd.BXB2026-04-14
00888912267588CHATTANOOGADJO, LLCBXB2026-03-31
00888912267618CHATTANOOGADJO, LLCBXB2026-03-31
00888912267625CHATTANOOGADJO, LLCBXB2026-03-31
00888912267632CHATTANOOGADJO, LLCBXB2026-03-31
04041925006230THERA-Trainer bemomedica - Medizintechnik GmbHBXB2026-03-16
04041925006247THERA-Trainer bemomedica - Medizintechnik GmbHBXB2026-03-16
09120077180212AMADEOtyromotion GmbHBXB2026-03-12
09120077180236DIEGOtyromotion GmbHBXB2026-03-12
09120077180243OMEGOtyromotion GmbHBXB2026-03-12
04041925006254THERA-Trainer toromedica - Medizintechnik GmbHBXB2025-12-16
04041925006261THERA-Trainer toro medica - Medizintechnik GmbHBXB2025-12-16
04041925006278THERA-Trainer toro medica - Medizintechnik GmbHBXB2025-12-16
04041925006285THERA-Trainer toro medica - Medizintechnik GmbHBXB2025-12-16
04041925006308OmniCycle® Revo medica - Medizintechnik GmbHBXB2025-12-16
04041925006315OmniCycle® Revomedica - Medizintechnik GmbHBXB2025-12-16
EJKP100004088A0Recovery 7200 PFJK-Products GmbHBXB2025-12-10
EJKP100004192A0Red Wave Recovery JK-Products GmbHBXB2025-10-30
00860005350827AMBLENextstep Robotics, Inc.BXB2025-09-29
04041925006193THERA-Trainer toromedica - Medizintechnik GmbHBXB2025-09-04
04041925006179THERA-Trainer tigomedica - Medizintechnik GmbHBXB2025-08-28