# PulseGuard International Ltd · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For PulseGuard International Ltd · 89-08 · UNITED KINGDOM, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is UNITED KINGDOM; product is Pulse Guard Package | Pulse Guard Package; product code is 74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 84 P - - OS Physiological signal based seizure monitoring system; date published is 08/01/2019; address is Unit 1, Crown Yard, Bedgebury Rd , Goudhurst, Kent UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** PulseGuard International Ltd _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** Unit 1, Crown Yard, Bedgebury Rd , Goudhurst, Kent UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 08/01/2019 _(verified: appears in the quote below)_
- **Product code:** 74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 84 P - - OS Physiological signal based seizure monitoring system _(verified: each item appears in the quote below)_
- **Product:** Pulse Guard Package | Pulse Guard Package _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580 | Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580 _(verified: each item appears in the quote below)_

## What the source says

> PulseGuard International Ltd Date Published : 08/01/2019 Unit 1, Crown Yard, Bedgebury Rd , Goudhurst, Kent UNITED KINGDOM 74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Date Published: 08/01/2019 Desc: Pulse Guard Package Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580 84 P - - OS Physiological signal based seizure monitoring system Date Published: 08/01/2019 Desc: Pulse Guard Package Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).