JAS Pulse 3MHz

FDA UDI

Class II (US FDA UDI)

by Axiosonic, Llc

Identity

Trade Name: JAS Pulse 3MHz FDA UDI
Generic Name: Physical therapy ultrasound system FDA UDI
Device Name: A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound device and power supply. FDA UDI
Model / Reference: 64-405-0005 FDA UDI
Description: A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound device and power supply. FDA UDI

Identifiers

Primary DI / UDI-DI: 00861681000310 FDA UDI
510(k) Number: K161628 FDA UDI
FDA Product Code: IMI FDA UDI
GMDN Term: Physical therapy ultrasound system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5300 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

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Physical therapy ultrasound system

JAS Pulse 3MHz by Axiosonic, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K161628 also covers:

AxioSonic Physiotherapy — AXIOSONIC, LLC
JAS Pulse — AXIOSONIC, LLC

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 II	Pending data

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Manufacturer

Manufacturer: Axiosonic, Llc

Sources (1)

FDA UDI 4d90ed5a-461a-4f70-a80c-57db876a2fa5 34 fields · synced May 30, 2026