Empulse M90

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref CAT-SW-2W24Model M90510(k) K242327

by Concourse Assistive Technology Pty Ltd

Identity

Trade Name: Empulse M90 EUDAMED
CONCOURSE ASSISTIVETECHNOLOGY PTY LTD FDA UDI
Generic Name: Wheelchair electric-motor-driven propulsion system FDA UDI
Device Name: Empulse M90 EUDAMED
The M90 is a medical device that allows a user to add a powered option to a manual wheelchair. The design intent is to be as non-intrusive and easy to integrate with a manual wheelchair as possible. This has myriad benifits to the end user, such as a sleek and subtle design with wireless operation, expedient configuration by the dealer/ocupational therapist, and ability to add a powered option to a wheelchair that the user is familiar with. The M90 is intended to be used to provide power assistance to manual wheelchair users who are limited in their field of activities because of their physical conditions. It is designed to augment or replace the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair. The M90 will be used by: • Wheelchair Occupant • Carer • Therapist • Technician and Installer • Sales Personnel FDA UDI
Model / Reference: M90 EUDAMEDFDA UDI
CAT-SW-2W24 EUDAMED
Description: The M90 is a medical device that allows a user to add a powered option to a manual wheelchair. The design intent is to be as non-intrusive and easy to integrate with a manual wheelchair as possible. This has myriad benifits to the end user, such as a sleek and subtle design with wireless operation, expedient configuration by the dealer/ocupational therapist, and ability to add a powered option to a wheelchair that the user is familiar with. The M90 is intended to be used to provide power assistance to manual wheelchair users who are limited in their field of activities because of their physical conditions. It is designed to augment or replace the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair. The M90 will be used by: • Wheelchair Occupant • Carer • Therapist • Technician and Installer • Sales Personnel FDA UDI

Identifiers

Primary DI / UDI-DI: 93090019370034 EUDAMEDFDA UDI
Basic UDI-DI: 930900193724M90LP EUDAMED
Direct Marketing DI: 93090019370034 EUDAMED
510(k) Number: K242327 FDA UDI
FDA Product Code: ITI FDA UDI
EMDN Code: Y122410 ELECTRIC PROPULSION UNIT EUDAMED
GMDN Term: Wheelchair electric-motor-driven propulsion system FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 890.3860 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Empulse M90 by Concourse Assistive Technology Pty Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K242327	Class I	Active
EUDAMED	European Union	CE/MDR	930900193724M90LP	Class I	Active

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Manufacturer

Manufacturer: Concourse Assistive Technology Pty Ltd
EUDAMED SRN: AU-MF-000043364
FDA Applicant: Concourse Assistive Technology Pty, Ltd.
Authorised Representative: Sunrise Medical GmbH DE-AR-000006321

Sources (3)

EUDAMED 324f062c-fdca-4355-99e1-f09a7464a64d 85 fields · synced Jun 18, 2026
FDA UDI 8e2ae863-52ee-45c3-9ada-5d863fc7a69d 34 fields · synced May 30, 2026
FDA 510(k) K242327 1 fields · synced May 18, 2026