Omniwave™

FDA UDI

Class I (US FDA UDI)

by Global Good, Corp.

Identity

Trade Name: Omniwave™ FDA UDI
Generic Name: Freestanding electric massager FDA UDI
Device Name: Omniwave is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains. Indications of use of Omniwave is intended for: Relief of minor muscle aches and pains; Temporary increase in local blood circulation; Activation of connective tissue. FDA UDI
Model / Reference: Quasoniq™ FDA UDI
Description: Omniwave is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains. Indications of use of Omniwave is intended for: Relief of minor muscle aches and pains; Temporary increase in local blood circulation; Activation of connective tissue. FDA UDI

Identifiers

Catalog Number: 042.001 FDA UDI
Primary DI / UDI-DI: 00860014139901 FDA UDI
FDA Product Code: ISA FDA UDI
GMDN Term: Freestanding electric massager FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Freestanding electric massager

Omniwave™ by Global Good, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Freestanding electric massager.

icoone Laser Healthcare — I-Tech Industries Srl · Class I
PR Cell 2G — Silhouet-Tone Corporation · Class I
G5® — GENERAL PHYSIOTHERAPY INC · Class I
OW100S — MTS Medical AG · Class I
FLOWELL — Xiamen Weiyou Intelligent Technology Co., Ltd · Class II
FLOWELL — Xiamen Weiyou Intelligent Technology Co., Ltd · Class II
CareCellve Wave Plus — General Bio Co., Ltd. · Class I
VU — Xiamen Weiyou Intelligent Technology Co., Ltd · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Global Good, Corp.

Sources (1)

FDA UDI ff5e2072-e416-4f23-9140-2a25fefc1aaa 34 fields · synced May 29, 2026