Cyrex Limited · 89-08 · UNITED KINGDOM
For Cyrex 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 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 2026-09-30.
- 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
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html