← Product Code [DXQ](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXQ) · K010686

# KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C (K010686)

_Golden Horse Medical Equipment (Wuxi) Co. , Ltd. · DXQ · Mar 21, 2001 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXQ/K010686

## Device Facts

- **Applicant:** Golden Horse Medical Equipment (Wuxi) Co. , Ltd.
- **Product Code:** [DXQ](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXQ.md)
- **Decision Date:** Mar 21, 2001
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 870.1120
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** 3rd-Party Reviewed

## Regulatory Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXQ/K010686](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXQ/K010686)

**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