Footswitch

FDA UDI

Class II (US FDA UDI)

by Northgate Technologies Inc.

Identity

Trade Name: Footswitch FDA UDI
Generic Name: Electrohydraulic lithotripsy system FDA UDI
Device Name: Pneumatic footswitch for use with Lithotripters FDA UDI
Model / Reference: 9-001-00 FDA UDI
Description: Pneumatic footswitch for use with Lithotripters FDA UDI

Identifiers

Catalog Number: 9-001-00 FDA UDI
Primary DI / UDI-DI: 00817183020011 FDA UDI
510(k) Number: K923822 FDA UDI
FDA Product Code: FFK FDA UDI
GMDN Term: Electrohydraulic lithotripsy system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4480 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrohydraulic lithotripsy system

Footswitch by Northgate Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrohydraulic lithotripsy system.

EHL-Probe — Walz Elektronik GmbH · Class II
EHL-Probe — Walz Elektronik GmbH · Class II
Electrohydraulic Lithotriptor — Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Class II
Econolith E3000 — Medispec, Ltd. · Class II
CyberWand — Gyrus Acmi, Inc. · Class II
EL27-Compact — Walz Elektronik GmbH · Class II
EHL Probe — Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Class II
CYBERWAND — Gyrus Acmi, Inc. · Class II

Cleared under the same submission

K923822 also covers:

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: Northgate Technologies Inc.

Sources (1)

FDA UDI f6ff4ff9-490c-4491-b702-bd78da99c8da 35 fields · synced Jun 8, 2026