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UltraTENSII

FDA UDI

Class II (US FDA UDI)

by Compass Health Brands Corp.

Identity

Trade Name
UltraTENSII FDA UDI
Generic Name
Physical therapy ultrasound system FDA UDI
Device Name
UltraTENS II - Ultrasound and FDA UDI
Model / Reference
DU6012 FDA UDI
Description
UltraTENS II - Ultrasound and FDA UDI

Identifiers

Primary DI / UDI-DI
00092237611630 FDA UDI
510(k) Number
K092627 FDA UDI
FDA Product Code
IMG FDA UDI
GMDN Term
Physical therapy ultrasound system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5860 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Physical therapy ultrasound system

UltraTENSII by Compass Health Brands Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Physical therapy ultrasound system.

Cleared under the same submission

K092627 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compass Health Brands Corp.

Sources (1)

  • FDA UDI 0f88b939-0c8e-43dc-84c0-e2bb0b3c894a 35 fields · synced May 30, 2026