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WAVE Clinical Platform

FDA UDI

Class II (US FDA UDI)

by Excel Medical Electronics, LLC

Identity

Trade Name
WAVE Clinical Platform FDA UDI
Generic Name
Medical equipment clinical data interfacing software FDA UDI
Device Name
The WAVE Clinical Platform software displays, routes, and stores medical device and diagnostic information from supported devices. FDA UDI
Model / Reference
NG FDA UDI
Description
The WAVE Clinical Platform software displays, routes, and stores medical device and diagnostic information from supported devices. FDA UDI

Identifiers

Primary DI / UDI-DI
00856128007007 FDA UDI
510(k) Number
K171056 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
Medical equipment clinical data interfacing software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 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

Category: Medical equipment clinical data interfacing software

WAVE Clinical Platform by Excel Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment clinical data interfacing software.

Cleared under the same submission

K171056 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Excel Medical Electronics, LLC

Sources (1)

  • FDA UDI 2db7d593-7603-4978-8f06-2e598421cace 34 fields · synced May 30, 2026