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

For Ionithermie Limited · 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 Ionithermie Machine | Ionithermie Machine | Ionithermie Machine | Ionithermie Machine; product code is 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 I - - RT Pad, Heating, Powered | 89 I - - SA Massager, Therapeutic, Electric; date published is 12/27/2012; address is Princess Beatrice House , 57 Victoria Street , Windsor, Berkshire UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** Ionithermie Limited _(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:** Princess Beatrice House , 57 Victoria Street , Windsor, Berkshire UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 12/27/2012 _(verified: appears in the quote below)_
- **Product code:** 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 I - - RT Pad, Heating, Powered | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Ionithermie Machine | Ionithermie Machine | Ionithermie Machine | Ionithermie Machine _(verified: each item appears in the quote below)_
- **FDA notes:** class II | class II | class II | class II _(verified: each item appears in the quote below)_

## What the source says

> Ionithermie Limited Date Published : 12/27/2012 Princess Beatrice House , 57 Victoria Street , Windsor, Berkshire UNITED KINGDOM 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes Date Published: 12/27/2012 Desc: Ionithermie Machine Notes: class II 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 12/27/2012 Desc: Ionithermie Machine Notes: class II 89 I - - RT Pad, Heating, Powered Date Published: 12/27/2012 Desc: Ionithermie Machine Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 12/27/2012 Desc: Ionithermie Machine Notes: class II

## The same source also states

> Ionithermie Limited Date Published : 12/27/2012 Windsor Area Police Station , 9-11 Alma Road , Windsor, Berkshire UNITED KINGDOM 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes Date Published: 12/27/2012 Desc: Ionithermie Machine Notes: Class II 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 12/27/2012 Desc: Ionithermie Machine Notes: Class II 89 I - - RT Pad, Heating, Powered Date Published: 12/27/2012 Desc: Ionithermie Machine Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 12/27/2012 Desc: Ionithermie Machine Notes: Class II

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

## 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/).