Medical Device Tracking Guidance for Industry And FDA Staff March 2025 > 자유게시판

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FDA is issuing this guidance to announce that both the checklist of units topic to medical gadget tracking necessities, iTagPro tracker and the checklist of medical gadgets released from tracking necessities, have been updated. This up to date guidance identifies all affected gadgets (these tracked and people released from tracking) in desk format. The desk consists of two fields to describe every gadget: (1) product code (procode) and (2) the standardized procode definition (product code - most well-liked term). These two descriptive fields are supposed to supply clarity about which devices are tracked. The product code and most well-liked name are usually found in the approval or clearance letter issued by CDRH. FDA's steerage paperwork, together with this steering, don't establish legally enforceable obligations. Instead, guidances describe the Agency's current pondering on a topic and iTagPro geofencing needs to be viewed only as suggestions, until particular regulatory or statutory requirements are cited. The use of the phrase ought to in Agency guidances means that something is instructed or recommended, however not required.

The invention relates to a large-angle clever solar iTagPro tracker, which includes a shifting platform and a hard and fast platform, iTagPro technology and a first branch chain I, a second department chain II, a 3rd department chain III, and a fourth branch chain are put in between the shifting platform and the fastened platform. IV, the first department I and the third branch III have the identical structure and are symmetrically organized, and the second branch II and the fourth department IV have the same construction and are symmetrically organized; the primary branch I includes the first connecting rod, and ItagPro the first connecting rod The upper finish of the rod is related with the shifting platform via the ball pair, the decrease finish of the first connecting rod is related with the primary Hooke hinge, and the primary Hooke hinge is connected with the fixed platform by the first connecting block via the primary shifting pair; the second branch chain II Including the second connecting rod, the higher end of the second connecting rod is related with the moving platform via the second Hooke hinge, the decrease finish of the second connecting rod is connected with the second connecting block via the rotating pair, and the second connecting block and the mounted platform are moved by means of the second Secondary connection.

The four department chains of the current invention type an area parallel closed-loop construction with the shifting platform and the fastened platform, which may notice two-dimensional translation and two-dimensional rotational motion in space. 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 specifically pertains to a four-diploma-of-freedom single-platform massive-rotation-angle intelligent sun tracker that may realize exact monitoring in environments equivalent 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 often composed of a dynamic platform, a static platform and several other branch chains between the 2 platforms. It has the advantages of excessive rigidity, quick velocity and high precision. It is widely utilized in industrial robots, movement simulators, parallel machine tools and different fields. Lately, foreign countries have successively applied some mechanism configurations to industrial production (similar to: delta mechanism), whereas there are fewer domestic ones, and they're not often used in production and iTagPro smart tracker 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, attitude leveling, solar tracking, and parallel machine instruments, it is usually crucial to attain large displacements, giant rotation angles, and ItagPro motions inside a large 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。