Vitalia Health Ltdharleyford · 89-08 · UNITED KINGDOM
For Vitalia Health Ltdharleyford, import alert is 89-08; country is UNITED KINGDOM; 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)"; 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 2026-09-30.
- Firm
- Vitalia Health Ltdharleyford verified
- 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
- Address
- Harleyford Henley Road , Marlow, UNITED KINGDOM verified
- Date published
- 06/08/2010 verified
- Product code
- 89 M - - BQ Device, Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing verified
- Product
- Magnessage Device verified
- FDA notes
- Lacks 510(K) verified
What the source says
Vitalia Health Ltdharleyford Date Published : 06/08/2010 Harleyford Henley Road , Marlow, UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
89 M - - BQ Device, Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing Date Published: 06/08/2010 Desc: Magnessage Device Notes: Lacks 510(K)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html