# Vitalia Health Ltdharleyford · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For Vitalia Health Ltdharleyford · 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 Magnessage Device; product code is 89 M - - BQ Device, Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing; date published is 06/08/2010; address is Harleyford Henley Road , Marlow, UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** Vitalia Health Ltdharleyford _(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:** Harleyford Henley Road , Marlow, UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 06/08/2010 _(verified: appears in the quote below)_
- **Product code:** 89 M - - BQ Device, Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing _(verified: appears in the quote below)_
- **Product:** Magnessage Device _(verified: appears in the quote below)_
- **FDA notes:** Lacks 510(K) _(verified: appears in the quote below)_

## What the source says

> Vitalia Health Ltdharleyford Date Published : 06/08/2010 Harleyford Henley Road , Marlow, UNITED KINGDOM 89 M - - BQ Device, Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing Date Published: 06/08/2010 Desc: Magnessage Device Notes: Lacks 510(K)

## 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/).