Medical Device Tracking Guidance For Industry And FDA Staff March 2025

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FDA is issuing this steering to announce that both the list of devices subject to medical machine monitoring necessities, and the list of medical units launched from tracking necessities, have been updated. This up to date guidance identifies all affected gadgets (those tracked and those launched from monitoring) in desk format. The desk includes two fields to explain every gadget: (1) product code (procode) and (2) the standardized procode definition (product code - preferred time period). These two descriptive fields are supposed to supply readability about which devices are tracked. The product code and preferred title are usually discovered in the approval or clearance letter issued by CDRH. FDA's steering paperwork, together with this steering, do not set up legally enforceable responsibilities. Instead, guidances describe the Agency's current considering on a subject and must be considered solely as suggestions, except particular regulatory or statutory requirements are cited. The usage of the word ought to in Agency guidances implies that something is prompt or really helpful, but not required.



The invention relates to a large-angle intelligent solar tracker, which features a transferring platform and a set platform, and a first branch chain I, a second branch chain II, a 3rd department chain III, and iTagPro Brand a fourth branch chain are installed between the moving platform and the mounted platform. IV, the primary department I and the third branch III have the same construction and are symmetrically arranged, iTagPro Tracker and the second branch II and the fourth department IV have the same construction and iTagPro Brand are symmetrically arranged; the first branch I contains the primary connecting rod, and iTagPro Brand the first connecting rod The higher finish of the rod is linked with the transferring platform through the ball pair, the lower end of the first connecting rod is related with the first Hooke hinge, and the primary Hooke hinge is linked with the fastened platform by way of the first connecting block via the first moving pair; the second department chain II Including the second connecting rod, the higher finish of the second connecting rod is linked with the shifting platform by way of the second Hooke hinge, the decrease finish of the second connecting rod is connected with the second connecting block by way of the rotating pair, and the second connecting block and the fastened platform are moved by means of the second Secondary connection.



The four department chains of the current invention type a space parallel closed-loop structure with the moving platform and the fixed platform, which can understand iTagPro Brand two-dimensional translation and two-dimensional rotational motion in area. 本发明属于并联机器人领域,特别涉及一种应用于定位、气象、雷达等环境下能够实现精确跟踪的四自由度单平台大转角智能太阳追踪器。 The invention belongs to the sector of parallel robots, and specifically pertains to a 4-diploma-of-freedom single-platform giant-rotation-angle clever sun tracker that may realize exact tracking in environments akin to positioning, meteorology, and radar. 并联机构通常由动平台、静平台及两平台之间的若干支链组成,具有刚度大、速度快、精度高的优点,在工业机器人、运动模拟器、并联机床等领域得到广泛应用。



近些年,国外已将陆续将部分机构构型应用于工业生产中(如:delta机构),而国内则较少,而且很少应用在生产生活中。 The parallel mechanism is usually composed of a dynamic platform, a static platform and a number of other branch chains between the 2 platforms. It has some great benefits of high rigidity, fast velocity and high precision. It's extensively used in industrial robots, movement simulators, parallel machine tools and different fields. Lately, international countries have successively applied some mechanism configurations to industrial manufacturing (corresponding to: delta mechanism), while there are fewer domestic ones, and they are hardly ever used in manufacturing and life.