Neurodyn V2.0, Neurodyn Aussie V2.0
by Ibramed Equipamentos Médicos
510(k) K210572
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210572 | Date11 May 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IPF
- FDA applicant
- Ibramed Equipamentos Medicos
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Neurodyn V2.0, Neurodyn Aussie V2.0 is a Physical Medicine device. It is a medical device manufactured by Ibramed Equipamentos Medicos.
The device received FDA 510(k) clearance on 2021-05-11 under clearance number K210572. It is classified as a Class 2 device with product code IPF and was cleared through the Traditional 510(k) pathway.
Other devices from Ibramed Equipamentos Médicos
Questions
AI-generated answers, 24 Sep 2026
What is the Neurodyn V2.0 used for?
The Neurodyn V2.0 is a Physical Medicine device, as indicated by its product code IPF and advisory committee classification PM, intended for use in physical medicine applications based on its FDA 510(k) clearance as substantially equivalent to a predicate device.
How was the Neurodyn V2.0 cleared for market release?
The Neurodyn V2.0 received FDA 510(k) clearance through the Traditional pathway on May 11, 2021, under clearance number K210572, after being found substantially equivalent to a legally marketed device, which is the standard regulatory route for moderate-risk Class 2 devices.
Who manufactures the Neurodyn V2.0 and where are they located?
The Neurodyn V2.0 is manufactured by Ibramed Equipamentos Medicos, located at Av. Dr. Carlos Burgos, 2800 - Jardim Itália, Amparo, Brazil, with postal code 13901-080, as listed in the device’s FDA 510(k) submission details.