Data / Medical devices / Malaysia / P Scientific Sdn. Bhd.
P Scientific Sdn. Bhd.: FDA-registered device maker in Masai Johor, Malaysia, 2 510(k) clearances
P Scientific Sdn. Bhd. is registered with the FDA (registration 3027241812) in Masai Johor, Malaysia. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 28, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027241812
- Address
- No.18, 18-01 & 18-02, Jalan Permas 9/16, Bandar Baru Permas Jaya, Masai Johor, Malaysia, 81750
- Owner or operator
- P Scientific Sdn. Bhd. (10087827)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 15, 2023
- Registered through
- 2026
- Brand names listed
- AMPCARE ESP Therapy System, Ampcare ES
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interferential Current Therapy | LIH | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 28, 2014 | K140168 | EASYSTIM TN28_OTC | NUH | Substantially Equivalent | Easymed Instruments Co., Ltd. | accessdata.fda.gov |
| October 31, 2013 | K131222 | AMPCARE ESP THERAPY SYSTEM | IPF | Substantially Equivalent | Ampcare, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electrical, Transcutaneous, For Arthritis
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Interferential Current Therapy
Updated August 28, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.