Reference Source

I.MANAGEMENT · 89-08 · FRANCE

For I.MANAGEMENT · 89-08 · FRANCE, 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 FRANCE; 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 2026-09-16.

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 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

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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