# Osim International (S) Pte Ltd · 89-08 · SINGAPORE — FDA import alert red lists: firms subject to detention without physical examination

For Osim International (S) Pte Ltd · 89-08 · SINGAPORE, 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 SINGAPORE; product is Blood Pressure Monitors Massagers Muscle Stimulators | Blood Pressure Monitors Massagers Muscle Stimulators | Blood Pressure Monitors Massagers Muscle Stimulators | Blood Pressure Monitors Massagers Muscle Stimulators | Blood Pressure Monitors Massagers Muscle Stimulators | Blood Pressure Monitors Massagers Muscle Stimulators; product code is 74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive | 74 D - - XQ Cuff, Blood-Pressure | 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric | 89 M - - PH Stimulator, Electrical, Muscle | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 09/16/2009; address is 240, Macpherson Road, 07-01 Pines , Singapore, SINGAPORE, verified against its source on 2026-09-16.

- **Firm:** Osim International (S) Pte Ltd _(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:** SINGAPORE _(verified: appears in the quote below)_
- **Address:** 240, Macpherson Road, 07-01 Pines , Singapore, SINGAPORE _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive | 74 D - - XQ Cuff, Blood-Pressure | 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric | 89 M - - PH Stimulator, Electrical, Muscle | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning _(verified: each item appears in the quote below)_
- **Product:** Blood Pressure Monitors Massagers Muscle Stimulators | Blood Pressure Monitors Massagers Muscle Stimulators | Blood Pressure Monitors Massagers Muscle Stimulators | Blood Pressure Monitors Massagers Muscle Stimulators | Blood Pressure Monitors Massagers Muscle Stimulators | Blood Pressure Monitors Massagers Muscle Stimulators _(verified: each item appears in the quote below)_
- **FDA notes:** Class III; 4/29/2005 | Class III; 4/29/2005 | Class III; 4/29/2005 | Class III; 4/29/2005 | Class III; 4/29/2005 | Blood Pressure Monitors Massagers Muscle Stimulators; Class III; 4/29/2005 | Class III; 4/29/2005 _(verified: each item appears in the quote below)_

## What the source says

> Osim International (S) Pte Ltd Date Published : 09/16/2009 240, Macpherson Road, 07-01 Pines , Singapore, SINGAPORE 74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive Date Published: 01/30/2019 Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/2005 74 D - - XQ Cuff, Blood-Pressure Date Published: 01/30/2019 Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/2005 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 01/30/2019 Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/2005 89 I - - PF Stimulator, Muscle, Powered Date Published: 01/30/2019 Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/2005 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/30/2019 Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/2005 89 M - - PH Stimulator, Electrical, Muscle Date Published: 09/16/2009 Notes: Blood Pressure Monitors Massagers Muscle Stimulators; Class III; 4/29/2005 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 01/30/2019 Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/2005

## 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/).