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Neurovirtual

FDA UDI

Class II (US FDA UDI)

by Neurovirtual Usa, Inc.

Identity

Trade Name
Neurovirtual FDA UDI
Generic Name
Polysomnograph FDA UDI
Device Name
Maxxi Rip Adjustable inductive belt is a device intended to capture respiratory effort from a patient and output the signal to a PSG device for sleep studies. FDA UDI
Model / Reference
Maxxi RIP Adjustable Inductive Belt FDA UDI
Description
Maxxi Rip Adjustable inductive belt is a device intended to capture respiratory effort from a patient and output the signal to a PSG device for sleep studies. FDA UDI

Identifiers

Catalog Number
SI1659 FDA UDI
Primary DI / UDI-DI
00850008393105 FDA UDI
510(k) Number
K171304 FDA UDI
FDA Product Code
MNR FDA UDI
GMDN Term
Polysomnograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Polysomnograph

Neurovirtual by Neurovirtual Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polysomnograph.

Cleared under the same submission

K171304 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurovirtual Usa, Inc.

Sources (1)

  • FDA UDI d98136b9-a552-4bb9-9d03-40f5a65f8b59 36 fields · synced Jun 6, 2026