Data / Medical devices / India / Neurostimulation Medtech Private Limited
Neurostimulation Medtech Private Limited: FDA-registered device maker in Chennai Tamil Nadu, India, 8 510(k) clearances
Neurostimulation Medtech Private Limited is registered with the FDA (registration 3010350335) in Chennai Tamil Nadu, India. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 13, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010350335
- Address
- Meerlan Towers, 1st Floor, No. 33 Hanumantha Road, Balaji Nagar, Royapettah, Chennai Tamil Nadu, India, 600014
- Owner or operator
- Neurostimulation Medtech Private Limited (10030051)
- Roles
- Manufacturer
- First device listed
- July 20, 2017
- Registered through
- 2027
- Brand names listed
- ANSiStim, Drug Relief, First Relief, First Relief v1, OpiRelief Plus, Primary Relief
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Locator, Acupuncture Point | BWJ | 2 | Manufacturer | accessdata.fda.gov |
| Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) | QHH | 2 | Manufacturer | accessdata.fda.gov |
| Percutaneous Nerve Stimulator For Opioid Withdrawal | PZR | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electro-Acupuncture | BWK | U | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | NHI | 2 | 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 |
|---|---|---|---|---|---|---|
| September 13, 2022 | K221425 | Primary Relief | NHI | Substantially Equivalent | Dyansys, Inc. | accessdata.fda.gov |
| June 6, 2022 | K221231 | Drug Relief v1 | PZR | Substantially Equivalent | Dyansys, Inc. | accessdata.fda.gov |
| May 12, 2022 | K220397 | ANSiStim-PP | NHI | Substantially Equivalent | Dyansys, Inc. | accessdata.fda.gov |
| January 31, 2022 | K213188 | Primary Relief | NHI | Substantially Equivalent | Dyansys, Inc. | accessdata.fda.gov |
| December 20, 2021 | K212859 | First Relief | NHI | Substantially Equivalent | Dyansys, Inc. | accessdata.fda.gov |
| December 29, 2020 | K202940 | First Relief v1 | QHH | Substantially Equivalent | Dyansys, Inc. | accessdata.fda.gov |
| May 2, 2018 | K173861 | Drug Relief | PZR | Substantially Equivalent | Dyansys, Inc. | accessdata.fda.gov |
| March 9, 2017 | K170391 | ANSiStim-PP | BWK | Substantially Equivalent | Dyansys, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electro-Acupuncture
- All makers of Percutaneous Nerve Stimulator For Opioid Withdrawal
- All makers of Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
- All makers of Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
- All makers of Locator, Acupuncture Point
Updated September 13, 2022. 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.