Cyrex Limited · 89-08 · UNITED KINGDOM
For Cyrex 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 ElectraStim Electro Stimulator | ElectraStim Electro Stimulator | ElectraStim Electro Stimulator; product code is 78 L - - KY Device, External Penile Rigidity | 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 89 I - - SA Massager, Therapeutic, Electric; date published is 03/18/2013; address is M5 The Maltings , Stanstead Abbots , Herfordshire, UNITED KINGDOM, verified against its source on 2026-09-16.
- Firm
- Cyrex 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
- M5 The Maltings , Stanstead Abbots , Herfordshire, UNITED KINGDOM verified
- Date published
- 03/18/2013 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity | 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- ElectraStim Electro Stimulator | ElectraStim Electro Stimulator | ElectraStim Electro Stimulator each item verified
- FDA notes
- Class II | class II | class II each item verified
What the source says
Cyrex Limited Date Published : 03/18/2013 M5 The Maltings , Stanstead Abbots , Herfordshire, UNITED KINGDOM 78 L - - KY Device, External Penile Rigidity Date Published: 03/18/2013 Desc: ElectraStim Electro Stimulator Notes: Class II 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use Date Published: 03/18/2013 Desc: ElectraStim Electro Stimulator Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 03/18/2013 Desc: ElectraStim Electro Stimulator Notes: class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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