ACTIV CARE TRANSCON GMBH · 89-08 · GERMANY
For ACTIV CARE TRANSCON GMBH, import alert is 89-08; country is GERMANY; 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 BioScan SWA Skalar-Wave Analyzer | BioScan SWA Skalar-Wave Analyzer; product code is 74 M - - SX System, Network and Communication, Physiological Monitors | 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief; date published is 05/30/2017; address is Zur Larche 53 , Nettetal, North Rhine-Westphalia GERMANY, verified against its source on 2026-09-30.
- Firm
- ACTIV CARE TRANSCON GMBH 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
- GERMANY verified
- Address
- Zur Larche 53 , Nettetal, North Rhine-Westphalia GERMANY verified
- Date published
- 05/30/2017 verified
- Product code
- 74 M - - SX System, Network and Communication, Physiological Monitors | 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief each item verified
- Product
- BioScan SWA Skalar-Wave Analyzer | BioScan SWA Skalar-Wave Analyzer each item verified
- FDA notes
- Class II device without a valid 510k | Class II device without a valid 510k each item verified
What the source says
ACTIV CARE TRANSCON GMBH Date Published : 05/30/2017 Zur Larche 53 , Nettetal, North Rhine-Westphalia GERMANY
— 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
74 M - - SX System, Network and Communication, Physiological Monitors Date Published: 05/30/2017 Desc: BioScan SWA Skalar-Wave Analyzer Notes: Class II device without a valid 510k 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 05/30/2017 Desc: BioScan SWA Skalar-Wave Analyzer Notes: Class II device without a valid 510k
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html