XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED · 89-08 · CHINA
For XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED, 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 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 2026-09-30.
- 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
— 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html