# QINGDAO C-PLUS LEATHER CO LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For QINGDAO C-PLUS LEATHER CO LTD · 89-08 · CHINA, 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 CHINA; product is Rhythm Tough Ultra (Nerve/Muscle Stimulator) | Rhythm Tough Ultra (Nerve/Muscle Stimulator); product code is 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 89 I - - PF Stimulator, Muscle, Powered; date published is 04/04/2017; address is 1000 Meters South West , Qingdao, CHINA, verified against its source on 2026-09-16.

- **Firm:** QINGDAO C-PLUS LEATHER CO LTD _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** 1000 Meters South West , Qingdao, CHINA _(verified: appears in the quote below)_
- **Date published:** 04/04/2017 _(verified: appears in the quote below)_
- **Product code:** 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 89 I - - PF Stimulator, Muscle, Powered _(verified: each item appears in the quote below)_
- **Product:** Rhythm Tough Ultra (Nerve/Muscle Stimulator) | Rhythm Tough Ultra (Nerve/Muscle Stimulator) _(verified: each item appears in the quote below)_

## What the source says

> QINGDAO C-PLUS LEATHER CO LTD Date Published : 04/04/2017 1000 Meters South West , Qingdao, CHINA 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 04/04/2017 Desc: Rhythm Tough Ultra (Nerve/Muscle Stimulator) 89 I - - PF Stimulator, Muscle, Powered Date Published: 04/04/2017 Desc: Rhythm Tough Ultra (Nerve/Muscle Stimulator)

## 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/).