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Sonopuls 494

FDA UDI

Class II (US FDA UDI)

by Enraf-Nonius B.V.

Identity

Trade Name
Sonopuls 494 FDA UDI
Generic Name
Multi-modality physical therapy system, professional-use FDA UDI
Device Name
Multi-modality (electrical stimulation/ultrasound/low level laser) physical therapy system FDA UDI
Model / Reference
1498941 FDA UDI
Description
Multi-modality (electrical stimulation/ultrasound/low level laser) physical therapy system FDA UDI

Identifiers

Primary DI / UDI-DI
08720618311139 FDA UDI
510(k) Number
K153559 FDA UDI
FDA Product Code
GZJ FDA UDI
IMG FDA UDI
IPF FDA UDI
ILY FDA UDI
GMDN Term
Multi-modality physical therapy system, professional-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
890.5860 FDA UDI
890.5850 FDA UDI
890.5500 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-modality physical therapy system, professional-use

Sonopuls 494 by Enraf-Nonius B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality physical therapy system, professional-use.

Cleared under the same submission

K153559 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Enraf-Nonius B.V.

Sources (1)

  • FDA UDI 8d501834-f8a7-4d10-b19d-8072afe3705e 35 fields · synced Jun 8, 2026