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Humero Tech

Titin Km Biomedical Corp. · Model C1 · UDI-DI 00860010519905

BXB

510(k) clearances

151

Adverse events

Recalls

116

Facilities

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.

Recalls

Date	Firm	Reason
2024-08-01	Btt Health Gmbh	Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical devic
2019-07-29	MOTEK MEDICAL B.V.	The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable gu
2013-06-12	Accelerated Care Plus Corporation	An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.
2012-11-12	BioMotion Medical Systems, LLC	BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involvin
2011-07-15	Alter-G, Incorporated	Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.
2009-05-27	Hocoma AG	Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation

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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.