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Applicator 9401

FDA UDI

Class II (US FDA UDI)

by Mettler Electronics Corp.

Identity

Trade Name
Applicator 9401 FDA UDI
Generic Name
Physical therapy ultrasound system applicator, hand-held FDA UDI
Device Name
940 applicator (Large size/ 1 & 3 MHz) FDA UDI
Model / Reference
9401 FDA UDI
Description
940 applicator (Large size/ 1 & 3 MHz) FDA UDI

Identifiers

Catalog Number
9401 FDA UDI
Primary DI / UDI-DI
00816864020661 FDA UDI
510(k) Number
K071137 FDA UDI
FDA Product Code
LIH FDA UDI
GZJ FDA UDI
IMG FDA UDI
GMDN Term
Physical therapy ultrasound system applicator, hand-held FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Physical therapy ultrasound system applicator, hand-held

Applicator 9401 by Mettler Electronics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Physical therapy ultrasound system applicator, hand-held.

Cleared under the same submission

K071137 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mettler Electronics Corp.

Sources (1)

  • FDA UDI 8d3c31ca-e2c1-40d1-8507-3688e5b8db0b 37 fields · synced May 30, 2026