QINGDAO C-PLUS LEATHER CO LTD · 89-08 · CHINA
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
- 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 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)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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