[KongchangAI]
Unverified85% confidenceDecision RuleTime unknown

医疗级镇痛应选取得二类医疗器械注册证(国械注准)的产品,注册证的‘适用范围’需明确包含‘缓解疼痛/镇痛’;仅有‘按摩保健’备案或无械字号的产品在电流参数和疗效上不受医疗监管约束

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