# INSTITUTE DR. RILLING INC. · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For INSTITUTE DR. RILLING INC. · 89-08 · GERMANY, 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 GERMANY; 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 Lilienthalweg 13 , Pliezhausen, GERMANY, verified against its source on 2026-09-16.

- **Firm:** INSTITUTE DR. RILLING INC. _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Lilienthalweg 13 , Pliezhausen, GERMANY _(verified: appears in the quote below)_
- **Date published:** 05/30/2017 _(verified: appears in the quote below)_
- **Product code:** 74 M - - SX System, Network and Communication, Physiological Monitors | 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief _(verified: each item appears in the quote below)_
- **Product:** BioScan SWA Skalar-Wave Analyzer | BioScan SWA Skalar-Wave Analyzer _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device without a valid 510k | Class II device without a valid 510k _(verified: each item appears in the quote below)_

## What the source says

> INSTITUTE DR. RILLING INC. Date Published : 05/30/2017 Lilienthalweg 13 , Pliezhausen, GERMANY 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).