← Product Code [IKK](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK) · K922092

# SINGLE CHAIR INTEGRAL BACK ATTACHMENT (K922092)

_Biodan Medical Systems, Ltd. · IKK · May 26, 1992 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K922092

## Device Facts

- **Applicant:** Biodan Medical Systems, Ltd.
- **Product Code:** [IKK](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK.md)
- **Decision Date:** May 26, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.1925
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.

## 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.

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K922092](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K922092)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com