Medical Device Tracking Guidance For Industry And FDA Staff March 2025
FDA is issuing this steerage to announce that both the record of units subject to medical machine monitoring necessities, and the checklist of medical devices launched from monitoring requirements, have been updated. This up to date guidance identifies all affected units (those tracked and people launched from tracking) in table format. The desk consists of two fields to explain each gadget: (1) product code (procode) and (2) the standardized procode definition (product code - most well-liked term). These two descriptive fields are intended to provide clarity about which gadgets are tracked. The product code and most popular name are typically found within the approval or clearance letter issued by CDRH. FDA's steering documents, together with this steerage, don't set up legally enforceable obligations. Instead, guidances describe the Agency's present thinking on a subject and ItagPro ought to be considered only as suggestions, except specific regulatory or statutory necessities are cited. The usage of the phrase should in Agency guidances signifies that something is prompt or beneficial, however not required.
The invention pertains to a large-angle intelligent solar tracker, which features a shifting platform and a set platform, and a first department chain I, ItagPro a second branch chain II, a third branch chain III, and a fourth department chain are installed between the transferring platform and the fastened platform. IV, the first department I and the third department III have the identical structure and are symmetrically arranged, and the second branch II and iTagPro USA the fourth department IV have the identical structure and are symmetrically arranged; the first branch I includes the first connecting rod, and the first connecting rod The higher end of the rod is linked with the moving platform by the ball pair, ItagPro the decrease finish of the primary connecting rod is related with the first Hooke hinge, ItagPro and the first Hooke hinge is related with the mounted platform through the first connecting block by way of the first moving pair; the second department chain II Including the second connecting rod, the higher finish of the second connecting rod is related with the shifting platform by way of the second Hooke hinge, the lower end of the second connecting rod is linked with the second connecting block through the rotating pair, and everyday tracker tool the second connecting block and the fixed platform are moved by means of the second Secondary connection.
The four department chains of the present invention type an area parallel closed-loop construction with the moving platform and the fastened platform, which can notice 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 sphere of parallel robots, and in particular relates to a four-diploma-of-freedom single-platform giant-rotation-angle intelligent solar tracker that can understand precise monitoring in environments comparable to positioning, iTagPro geofencing meteorology, and ItagPro 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 several branch chains between the 2 platforms. It has the benefits of high rigidity, quick pace and high precision. It is extensively used in industrial robots, motion simulators, parallel machine tools and ItagPro other fields. In recent years, international nations have successively applied some mechanism configurations to industrial manufacturing (akin to: delta mechanism), while there are fewer domestic ones, and they are hardly ever utilized in production and life. 在运动模拟器、姿态调平、太阳能追踪以及并联机床等领域，通常需要实现大位移、大转角，实现较大工作空间范围内的运动。
In the fields of motion simulators, perspective leveling, ItagPro solar monitoring, and parallel machine instruments, ItagPro it is normally vital to realize large displacements, massive rotation angles, and motions within a big working space. 国内太阳能发电普遍采用固定式太阳能电池安装方式，尽管这种安装方式结构简单、成本较低，但是无法精确跟踪太阳位置，光能转换效率较低。 现有研究中，也存在部分运动型太阳能机构，单轴或双轴等多为串联机构精度不高。 其中双轴的跟踪精度相对较高，太阳板能达到的转换效率相对较大，但遇到恶劣天气难以保证装置的安全性。