Reference Source

I.MANAGEMENT · 89-08 · FRANCE

For I.MANAGEMENT, import alert is 89-08; country is FRANCE; 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 Skeen Patch | Skeen Patch | Skeen Patch | Skeen Patch; product code is 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 84 G - - XY Electrode, Cutaneous | 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 89 I - - SA Massager, Therapeutic, Electric; date published is 08/02/2023; address is 80 Rue Curial , Paris, Paris FRANCE, verified against its source on 2026-09-30.

Firm
I.MANAGEMENT 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
FRANCE verified
Address
80 Rue Curial , Paris, Paris FRANCE verified
Date published
08/02/2023 verified
Product code
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 84 G - - XY Electrode, Cutaneous | 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 89 I - - SA Massager, Therapeutic, Electric each item verified
Product
Skeen Patch | Skeen Patch | Skeen Patch | Skeen Patch 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

I.MANAGEMENT Date Published : 08/02/2023 80 Rue Curial , Paris, Paris FRANCE

— 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 and Product

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 08/02/2023 Desc: Skeen Patch 84 G - - XY Electrode, Cutaneous Date Published: 08/02/2023 Desc: Skeen Patch 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use Date Published: 08/02/2023 Desc: Skeen Patch 89 I - - SA Massager, Therapeutic, Electric Date Published: 08/02/2023 Desc: Skeen Patch

— all from 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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