Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

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