Manufacturer

Performancehealth

United Kingdom (ex Northern Ireland), United StatesLegal entities : Performance Health International LTD, Performance Health Supply, LLC

Markets : France · United States

Approvals : EU – class I, IIa · United States (FDA) – · class I

Public contracts won : France 6

EU representative : AR Experts B.V. (Netherlands)

17 categories, 30 models including 30 on the market, 2 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Elbow crutches	Y12030601	Adjustable Forearm Crutches - 1/PR MOBILITY3 refs Days Adjustable Crutches MOBILITY Days Elbow Crutches MOBILITY3 refs	I MDR	EUDAMED record Report an error
Quadripods	Y120318	Days Domestic Walking Frame, Non-wheeled, Large MOBILITY3 refs DAYS FOUR-WHEELED ROLLATOR - QUARTZ MOBILITY3 refs DAYS STEEL ROLLATOR MOBILITY3 refs	I MDR	EUDAMED record Report an error
Knee orthoses	Y061209	KNEE IMMOBILISER ECONOMY THREE PANE ORTHOPEDICS3 refs KNEE IMMOBILISER ECONOMY THREE PANEL 46CM SMALL ORTHOPEDICS3 refs	I MDR	EUDAMED record Report an error
Medical beds - other accessories	V08068099	Homecraft Bed Rail, Double loop FALL PREVENTION & BED POSITIONING3 refs Homecraft Bed Rail, with legs FALL PREVENTION & BED POSITIONING3 refs	I MDR	EUDAMED record Report an error
Passive ankle-foot orthoses	Y06120601	AFO SPLINTS Orthopedics3 refs Vulkan Athletic Support ORTHOPEDICS3 refs	I MDR	EUDAMED record Report an error
Shoulder orthoses	Y060621	SHOULDER IMMOBILISER SLING ORTHOPEDICS3 refs Vulkan Classic 3018/3019 Half Shoulder Supports ORTHOPEDICS3 refs	I MDR	EUDAMED record Report an error
Spine orthoses - other	Y060399	BACK SUPPORT VULKAN RITE 7021 ORTHOPEDICS3 refs Vulkan Classic 3013 Back Support ORTHOPEDICS3 refs	I MDR	EUDAMED record Report an error
Walking devices, one-handed operation - other	Y120399	ADJUSTABLE ERGONOMIC HANDLE WALKING STICK MOBILITY2 refs Tripod & Quadruped Walking Sticks MOBILITY4 refs	I MDR	EUDAMED record Report an error
Walking trolleys	Y120612	Homecraft Deluxe Walker Trolley, Beige AIDS TO DAILY LIVING Homecraft Deluxe Walker Trolley, White AIDS TO DAILY LIVING	I MDR	EUDAMED record Report an error
Wheelchairs - other	Y122199	Days Chrome Plated Steel Wheelchair MOBILITY6 refs Days Escape Lite Wheelchair MOBILITY2 refs	I MDR	EUDAMED record Report an error
Wrist disarticulation prostheses	Y061806	THUMB SUPPORT BASIC ELASTIC SPICA ORTHOPEDICS3 refs Vulkan Wrist Brace ORTHOPEDICS3 refs	I MDR	EUDAMED record Report an error
Cervical spine orthoses	Y060312	Vulkan Medicollar ORTHOPEDICS3 refs	I MDR	EUDAMED record Report an error
Elbow disarticulation prostheses	Y061812	VULKAN TENNIS ELBOW BRACE ORTHOPEDICS3 refs	I MDR	EUDAMED record Report an error
Partial hand prostheses (including fingers prostheses)	Y061803	ROLYAN THUMB SUPPORT BASIC ELASTIC SPICA ORTHOPEDICS3 refs	I MDR	EUDAMED record Report an error
Pelvic floor rehabilitation devices - other	U070399	Neen2 refs93/42	IIa 93/42	EUDAMED record Report an error
Various physiotherapy and rehabilitation instruments - other	Z12069099	ROLYAN BALL HAND PIECE SKATEBOARD ACCESSORY - LEFT EXERCISE THERAPY3 refs	I MDR	EUDAMED record Report an error
Wrist-hand-fingers orthoses	Y060613	CUSTOM POSITIONER Orthopedics3 refs	I MDR	EUDAMED record Report an error

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