XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED · 89-08 · CHINA
For XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED · 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 Leg Massager with Heat | Leg Massager with Heat; product code is 89 I - - RP Massager, Powered Inflatable Tube | 89 I - - SA Massager, Therapeutic, Electric; date published is 11/22/2021; address is Building D Floor 2-3 , NO. 100 Jinfu Road; Tongan District , Xiamen, Fujian CHINA, verified against its source on 2026-09-16.
- Firm
- XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED 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
- Building D Floor 2-3 , NO. 100 Jinfu Road; Tongan District , Xiamen, Fujian CHINA verified
- Date published
- 11/22/2021 verified
- Product code
- 89 I - - RP Massager, Powered Inflatable Tube | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Leg Massager with Heat | Leg Massager with Heat each item verified
- FDA notes
- Only the following models are subject to the alert: EMK-702, EMK-707, EMK-703B, EMK-707B, SHI-66, SHI-77, RF-ALM072-H, EMK-712, RP-ALM075 | Only the following models are subject to the alert: EMK-702, EMK-707, EMK-703B, EMK-707B, SHI-66, SHI-77, RF-ALM072-H, EMK-712, RP-ALM075 each item verified
What the source says
XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED Date Published : 11/22/2021 Building D Floor 2-3 , NO. 100 Jinfu Road; Tongan District , Xiamen, Fujian CHINA 89 I - - RP Massager, Powered Inflatable Tube Date Published: 08/02/2023 Desc: Leg Massager with Heat Notes: Only the following models are subject to the alert: EMK-702, EMK-707, EMK-703B, EMK-707B, SHI-66, SHI-77, RF-ALM072-H, EMK-712, RP-ALM075 89 I - - SA Massager, Therapeutic, Electric Date Published: 08/02/2023 Desc: Leg Massager with Heat Notes: Only the following models are subject to the alert: EMK-702, EMK-707, EMK-703B, EMK-707B, SHI-66, SHI-77, RF-ALM072-H, EMK-712, RP-ALM075
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.