Ionithermie Limited · 89-08 · UNITED KINGDOM
For Ionithermie Limited, 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 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 listed twice: Princess Beatrice House , 57 Victoria Street , Windsor, Berkshire UNITED KINGDOM and Windsor Area Police Station , 9-11 Alma Road , Windsor, Berkshire UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- Ionithermie Limited 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
- Princess Beatrice House , 57 Victoria Street , Windsor, Berkshire UNITED KINGDOM verified
- Windsor Area Police Station , 9-11 Alma Road , Windsor, Berkshire UNITED KINGDOM also listed
- Date published
- 12/27/2012 verified
- 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 each item verified
- Product
- Ionithermie Machine | Ionithermie Machine | Ionithermie Machine | Ionithermie Machine each item verified
- FDA notes
- class II | class II | class II | class II each item verified
What the source says
Ionithermie Limited Date Published : 12/27/2012 Princess Beatrice House , 57 Victoria Street , Windsor, Berkshire 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
The same source also states
Ionithermie Limited Date Published : 12/27/2012 Windsor Area Police Station , 9-11 Alma Road , Windsor, Berkshire UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-15
Product code
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
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html