结论：产品代码由预期用途和技术特征共同决定，不是按外观选

产品代码对应特定的产品描述和监管要求。选择的依据是产品的预期用途和技术特征，而不是产品看起来像什么。

两个外观相似的轮椅，如果预期用途不同，可能对应不同的代码。 比如一款普通的电动轮椅与一款带康复训练功能的电动轮椅，虽然都是「电动轮椅」，但后者的预期用途中包含治疗性目的，归类可能不同。

选错代码的后果是： 按错误的要求准备资料，提交后被要求重新归类，前面的准备可能部分作废。

选择的依据

预期用途是首要依据。 产品用来做什么、用于什么人群、解决什么问题。

技术特征是第二依据。 驱动方式、控制方式、特殊功能。

与已有产品的比较。 市场上已有的同类产品用什么代码，是重要参考。

风险水平。 不同代码对应不同的风险等级和监管强度。

建议的做法是：先把预期用途写清楚，再据此查找匹配的代码。 预期用途写得含糊，代码的选择就没有依据。

轮椅相关代码的区分

轮椅类产品的代码区分主要看几个维度：

维度 影响
驱动方式 手动、电动、助力
使用者类型 成人、儿童
特殊功能 站立、倾斜、训练
使用场景 日常移动、康复治疗
是否含治疗性目的 影响归类与风险等级

「是否含治疗性目的」是关键区分点。 单纯提供移动功能的轮椅，与声称具有治疗或康复效果的轮椅，归类和监管要求可能明显不同。

这一点对宣称有直接影响 ——如果按单纯移动功能归类，就不应当宣称治疗效果；反过来，要宣称治疗效果，归类和证据要求都会提高。

特殊功能产品的处理

带特殊功能的产品，处理方式有几种思路：

按主要功能归类。 如果特殊功能是辅助性的，可能仍按轮椅归类，但要说明附加功能。

按更严的功能归类。 如果特殊功能带来更高风险，按该功能对应的类别归类。

分别归类。 某些情况下可能涉及多个代码。

咨询确认。 不确定时通过正式途径咨询。

判断的原则是看风险。 特殊功能是否带来了轮椅本身不具有的风险——比如站立功能带来跌落风险、爬楼功能带来坠落风险、训练功能带来过度负荷风险。带来新风险的功能，通常需要更高层级的考虑。

预期用途的表述

既然代码由预期用途决定，预期用途的表述就很关键：

要具体。 说清楚用于什么、用于谁、在什么场景。

要与宣称一致。 预期用途的表述与市场宣传材料不应矛盾。

要与证据匹配。 声称的用途要有相应的数据支撑。

不要过度扩展。 用途写得越宽，需要的证据越多。

不要含糊。 含糊的表述在审查中会被要求澄清。

「不要过度扩展」是实用的建议。 有些企业为了市场覆盖面把预期用途写得很宽，结果证据要求随之提高，反而拖慢了上市。建议先按核心用途上市，后续再考虑扩展。

不确定时的做法

遇到归类不确定的情况：

查找同类产品。 看市场上功能相近的产品用什么代码。

分析差异。 自己的产品与参照产品有什么不同，差异是否影响归类。

咨询专业人士。 熟悉该市场的顾问或代理人。

通过正式途径咨询。 某些情况下可以向主管部门咨询确认。

按较严的假设准备。 在确认之前，按较严的可能性准备证据，避免返工。

最后一条是稳妥的做法。 证据准备得充分一些，即使最终归入较宽松的类别也不浪费；反过来则要补做。

与证据准备的关系

代码确定之后，证据要求就清楚了：

适用的性能标准。 不同代码对应的标准清单不同。

需要的数据类型。 机械、电气、生物相容性、阻燃等。

是否需要临床证据。 涉及治疗性目的的产品可能需要。

特殊要求。 某些代码有特定的额外要求。

建议在代码确定之后，做一份证据清单 ——列出所有需要的数据、已有的、缺的，以及补足的计划。这份清单是后续工作的依据。

与其他市场的关系

各市场的分类规则不同，不能直接套用：

欧盟的分类规则不同。 按规则判定，与美国的代码体系不对应。

其他市场也各有体系。 不能假设分类结果一致。

但证据可以复用。 虽然分类不同，需要的技术数据高度重合。

所以多市场规划时，分类要逐个做，证据可以统一准备。 这一点前面讲报告复用时说过，这里同样适用。

代码与宣称的一致性

代码确定之后，产品的所有对外表述都应当与之一致：

产品说明书。 预期用途的表述。

包装与标签。 产品描述。

网站与宣传材料。 功能描述与效果宣称。

销售话术。 销售人员的介绍口径。

展会材料。 展示内容。

「宣传材料与归类不符」是常见的合规风险。 产品按移动功能归类，而宣传材料声称能改善某种症状——这种不一致一旦被注意到，可能引出归类和证据的问题。

建议在代码确定后，把所有对外材料过一遍，确认表述在归类的范围之内。这项检查成本不高，但能避免明确的风险。

变更时的重新评估

以下变化应当重新评估代码是否仍然适用：

增加新功能；扩展预期用途；改变目标使用人群；增加或修改效果宣称；以及产品的技术特征发生实质变化。

「增加效果宣称」是最容易触发重新归类的变化，因为它直接改变了预期用途。市场部门推动的宣称调整，应当经过合规确认。

我们的做法

承接轮椅委托时，如果委托方计划进入美国市场，我们会先了解产品的预期用途和特殊功能，因为这决定了需要覆盖哪些标准和项目。 特别是带治疗性宣称的产品，测试范围与单纯移动功能的产品不同。

测试方面，我们建议按覆盖面较广的口径一次做全，报告包含完整的条件和实测数据并出英文版本 ——这样无论最终归入哪一类，数据都够用。

如果你在确定轮椅产品的归类和测试范围，可以把产品资料和预期用途发过来一起讨论，或者直接联系：132 4819 8029。检测能力见服务介绍，产品分类见手动轮椅检测与电动轮椅检测，标准信息见标准查询。

English version

Conclusion. A product code corresponds to a particular product description and set of regulatory requirements. The basis for choosing one is the product's intended use and technical characteristics rather than what the product looks like. Two visually similar wheelchairs with different intended uses may fall under different codes: an ordinary powered chair and a powered chair with rehabilitation training functions are both powered wheelchairs, but the latter's intended use includes a therapeutic purpose and may be categorised differently. Choosing wrongly means preparing to the wrong requirements, being asked to reclassify after submission, and possibly wasting part of the preparation.

Basis for choosing. Intended use comes first: what the product does, for whom and what problem it addresses. Technical characteristics come second, covering drive type, control method and special functions. Comparison with existing products provides important reference, showing what codes similar marketed products use. And risk level matters, since different codes correspond to different risk classes and degrees of oversight. Write the intended use clearly first and then find the matching code; a vague intended use leaves the choice without a basis.

Distinguishing wheelchair codes. Several dimensions distinguish them. Drive type separates manual, powered and power-assisted. User type separates adult and paediatric. Special functions cover standing, tilt and training. Use context separates everyday mobility from rehabilitation therapy. And whether a therapeutic purpose is included affects both classification and risk class. The therapeutic purpose is the key distinction: a chair providing mobility alone and one claiming therapeutic or rehabilitative effect may differ markedly in classification and requirements. That bears directly on claims: a product classified as providing mobility alone should not claim therapeutic effect, and conversely, claiming therapeutic effect raises both classification and evidence requirements.

Handling special function products. Several approaches exist. Classify by principal function, where the special function is ancillary, keeping wheelchair classification while describing the additional function. Classify by the more demanding function, where the special function brings higher risk. Classify under several codes, which applies in some cases. Or seek confirmation through formal channels where uncertain. Judge by risk: does the special function introduce a hazard the wheelchair itself does not have, such as falling from a standing function, falling downstairs from a stair climbing function, or excessive loading from a training function. Functions introducing new hazards generally warrant higher-level consideration.

Wording the intended use. Since the code follows from intended use, its wording is critical. Be specific about what, for whom and in what context. Keep it consistent with claims, so that intended use and marketing material do not contradict one another. Match it to evidence, so that every claimed use has supporting data. Avoid over-extension, since broader use requires more evidence. And avoid vagueness, which attracts requests for clarification during review. Avoiding over-extension is practical advice: some manufacturers write intended use broadly for market reach, raising evidence requirements and delaying launch. Launch on the core use and consider extension later.

When uncertain. Look for similar products and the codes they use. Analyse the differences between your product and the comparator and whether those differences affect classification. Consult professionals familiar with the market, such as advisers or agents. Seek formal confirmation from the authority where that route is available. And prepare to the stricter assumption until confirmed, avoiding rework. The last is the prudent course: evidence prepared generously is not wasted if the product ultimately falls into a more lenient category, whereas the reverse requires further work.

Relationship to evidence preparation. Once the code is fixed, the evidence requirements become clear: the applicable performance standards, which differ by code; the data types needed, covering mechanical, electrical, biocompatibility and flammability; whether clinical evidence is required, as it may be for therapeutic purposes; and any specific additional requirements attaching to the code. Produce an evidence list once the code is settled, enumerating what is needed, what exists, what is missing and the plan to fill the gaps. That list underpins the work that follows.

Relationship to other markets. Classification rules differ between markets and cannot be transferred. The European rules are determined differently and do not map onto the United States code system. Other markets have their own systems too, and consistency cannot be assumed. Evidence, however, transfers well, since the technical data required overlap heavily. In multi-market planning, therefore, classify market by market while preparing evidence once, the same point made earlier about report reuse.

How we handle it. For wheelchair work aimed at the United States we establish the intended use and special functions first, since they determine which standards and items must be covered. Products carrying therapeutic claims need a different test scope from mobility-only products. On testing we suggest covering broadly in one pass, with reports containing complete conditions and measured data issued in English, so that the data suffice whatever the final classification.

Send us the product information and intended use and we will work through classification and test scope. Phone or WeChat: +86 132 4819 8029.