Reference Source

Ionithermie Limited · 89-08 · UNITED KINGDOM

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
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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

— 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 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

— accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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