QINGDAO C-PLUS LEATHER CO LTD · 89-08 · CHINA
For QINGDAO C-PLUS LEATHER CO LTD, import alert is 89-08; country is CHINA; 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 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 2026-09-30.
- Firm
- QINGDAO C-PLUS LEATHER CO LTD 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
- CHINA verified
- Address
- 1000 Meters South West , Qingdao, CHINA verified
- Date published
- 04/04/2017 verified
- Product code
- 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 89 I - - PF Stimulator, Muscle, Powered each item verified
- Product
- Rhythm Tough Ultra (Nerve/Muscle Stimulator) | Rhythm Tough Ultra (Nerve/Muscle Stimulator) each item verified
What the source says
QINGDAO C-PLUS LEATHER CO LTD Date Published : 04/04/2017 1000 Meters South West , Qingdao, CHINA
— 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 and Product
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)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html