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Humero Tech

Titin Km Biomedical Corp. · Model C1 HD · UDI-DI 00860010519912

ION

510(k) clearances

117

Adverse events (2 deaths)

Recalls

256

Facilities

Description

The Humero Tech C1 HD is an updated version of the Humero Tech C1 to better withstand strength and conditioning activities in addition to rehabilitation. The C1 HD 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 HD has an intended us of assisting with improving the strength, active range of motion, and motor control of the postoperative status, or when a deficit in power is noted. The device collects data and tracks range of motion to evaluate progress over time.

Recalls

Date	Firm	Reason
2015-03-27	Amtryke LLC	Product is being recalled due to complaints of cracked frames.
2011-07-11	North Coast Medical Inc	Potential for plastic D-ring to break during use and cause injury.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.