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Code · CFR · Title 21 — Food and Drugs · Part 890 — Physical Medicine Devices · § 890.3500

§ 890.3500. External assembled lower limb prosthesis.

86 words·~1 min read·/us/cfr/t21/s§ 890.3500·

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(a)Identification. An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.
(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
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§ 890.3500
External assembled lower limb prosthesis.
C.F.R.×1
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