21 CFR § 890.3490 - Truncal orthosis. | CFR | 合法醫療器材資訊網
§ 890.3490 Truncal orthosis.
(a) Identification. A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807[1] of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820[2] of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
...Food and Drug Administration | 合法醫療器材資訊網
Food and Drug Administration | 合法醫療器材資訊網
Food and Drug Administration | 合法醫療器材資訊網
21 CFR § 890.3490 - Truncal orthosis. | CFR | 合法醫療器材資訊網
台北哪個藥房有必利勁賣 | 合法醫療器材資訊網
21 CFR Ch. I (4–1–11 Edition) § 890.3475 | 合法醫療器材資訊網
21 CFR Ch. I (4–1–14 Edition) § 890.3490 | 合法醫療器材資訊網
21 CFR Ch. I (4–1–10 Edition) § 890.3475 | 合法醫療器材資訊網
【"伯安" 透氣束腹帶 (多條式)】許可證字號:衛署醫器製壹字第001201號
器材品名:"伯安"透氣束腹帶(多條式)許可證字號:衛署醫器製壹字第001201號註銷狀態:已註銷註銷日期:2012/11/30註銷理由:許可...