← Product Code [ISP](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ISP) · K843855

# ERGOTEST 40 & 45 (K843855)

_Erich Jaeger, Inc. · ISP · Nov 27, 1984 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ISP/K843855

## Device Facts

- **Applicant:** Erich Jaeger, Inc.
- **Product Code:** [ISP](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ISP.md)
- **Decision Date:** Nov 27, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3420
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ISP/K843855](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ISP/K843855)

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