# XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Building D Floor 2-3 , NO. 100 Jinfu Road; Tongan District , Xiamen, Fujian CHINA _(verified: appears in the quote below)_
- **Date published:** 11/22/2021 _(verified: appears in the quote below)_
- **Product code:** 89 I - - RP Massager, Powered Inflatable Tube | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Leg Massager with Heat | Leg Massager with Heat _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).