Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

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