Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3500](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3500) → ISW — Assembly, Knee/Shank/Ankle/Foot, External

# ISW · Assembly, Knee/Shank/Ankle/Foot, External

_Physical Medicine · 21 CFR 890.3500 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ISW

## Overview

- **Product Code:** ISW
- **Device Name:** Assembly, Knee/Shank/Ankle/Foot, External
- **Regulation:** [21 CFR 890.3500](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3500)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)

## 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.

## Classification Rationale

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.

## Special Controls

*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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K991590](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ISW/K991590.md) | C-LEG (3C100) | Otto Bock Orthopedic Industry, Inc. | Jul 8, 1999 | SESE |

## Top Applicants

- Otto Bock Orthopedic Industry, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ISW](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ISW)

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