Osim International (S) Pte Ltd · 89-08 · SINGAPORE
For Osim International (S) Pte Ltd, import alert is 89-08; country is SINGAPORE; 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 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 2026-09-30.
- Firm
- Osim International (S) Pte 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
- SINGAPORE verified
- Address
- 240, Macpherson Road, 07-01 Pines , Singapore, SINGAPORE verified
- Date published
- 09/16/2009 verified
- 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 each item verified
- 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 each item verified
- 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 each item verified
What the source says
Osim International (S) Pte Ltd Date Published : 09/16/2009 240, Macpherson Road, 07-01 Pines , Singapore, SINGAPORE
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html