Manufacturer

Zhangpu Ortholife Rehabilitation

ChinaLegal entities : Zhangpu Ortholife Rehabilitation Co., Ltd.

Markets : Austria · Belgium · Germany · Greece · Ireland · Italy · Netherlands · Poland · Romania · Spain · Sweden · United States

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

EU representative : SUNGO Europe B.V. (Netherlands)

14 categories, 17 models including 17 on the market, 1 country

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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
Orthoses, foot (including insoles and inserts)	Y061203	5th Toe Bunion Shield3 refs “U” Shaped Heel Cushion:640008 3/4 Arch Support:640010 3/5 Arch Support:640010 3/6 Arch Support:640010 3/7 Arch Support:640010 Full Length Cushioning Insole:640009 Full Length Insole:640001 Heel Cup Central Spur:640004 etc3 refs	I MDR	EUDAMED record Report an error
Passive ankle-foot orthoses	Y06120601	Air Walking Boot:635102 GoFit Walker:635302 Lite Ped.Walking Boot:638801 Power Walking Boot:635301 Pro Ped.Walking Boot:638802 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 ROM Walking Boot:635201 etc3 refs Athena Calf Support Plantar Fasciitis Compression Sock:610002 Diabetic Antibacterial Socks:610003 Diabetic Daily Socks:6100043 refs	I MDR	EUDAMED record Report an error
Shoulder orthoses	Y060621	Arm ABD Immobilizer:213106 Arm ABD Immobilizer:213107 Arm ABD Immobilizer:213108 Humeral Fracture Brace:210005 Mesh Sling:210001 Pillow Arm ABD Immobilizer:213103 Shoulder Abduction Immobilizer:213101 etc3 refs Clavicle Support:220004 Clavicle Support:220006 Posture Corrective Brace:220002 Posture Corrector:220005 Posture Support Brace:220001 Universal Clavicle Support:2200033 refs	I MDR	EUDAMED record Report an error
Cervical spine orthoses	Y060312	K Collar:121401 Rigid Splint Collar:120004 Rigid Splint Collar With Chin Support:120005 Soft Collar:120001 Soft Collar:120002 Tracheotomy Collar:1200033 refs	I MDR	EUDAMED record Report an error
Cervicothoracic spine orthoses	Y060315	Minerva CTO	I MDR	EUDAMED record Report an error
Elbow orthoses	Y060615	Airform Elbow Strap:310004 Airform Elbow Strap:310006 Athena Elbow Support:312003 Elastic Elbow Support:312001 Elastic Elbow Support:312002 Elbow Strap:310003 Elbow Strap:318002 Elbow Strap With Pad:310002 etc3 refs	I MDR	EUDAMED record Report an error
Heel, elbow and knee anti-decubitus protection aids	V0811	AFO Splint 620001 AFO Leaf Spring 620002 Dorsal Night Splint:620016 Night Splint:620003 Soft Night Splint:6200043 refs	I MDR	EUDAMED record Report an error
Hip orthoses (including abduction orthoses)	Y061215	Counter Hip Brace 260001(L/Left/Black)3 refs	I MDR	EUDAMED record Report an error
Knee orthoses	Y061209	Athena Knee Support Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:5270053 refs	I MDR	EUDAMED record Report an error
Lumbosacral spine orthoses	Y060308	Abdominal Binder:230001 Elastic Lumbar Support:231201 Lumbar Stabilizer:231206 Lumbar Support:231205 Lumbar Support With Stays:231202 Lumbar Support With Stays:238001 Lumbofit Panel Brace:231303 Lumbofit Support:231302 etc3 refs	I MDR	EUDAMED record Report an error
Sacroiliac spine orthoses	Y060303	RPS KNIT S1 BELT3 refs	I MDR	EUDAMED record Report an error
Thigh orthoses	Y061217	Athena Thigh Support:5120013 refs	I MDR	EUDAMED record Report an error
Thoracolumbar orthoses	Y060306	Jewett Hyperextension Brace3 refs	I MDR	EUDAMED record Report an error
Wrist (forearm) orthoses	Y060609	Athena Wrist Support:412003 CTS Wrist Orthosis:410009 Functional Position Splint:417001 Palm Brace:412001 Thumb Brace:412102 Thumb Brace:418003 Thumb Splint:412101 TPS THUMB BRACE:416601 TPS WRIST AND THUMB SPLINT:416602 Uni Thumb Brace:412104 etc3 refs	I MDR	EUDAMED record Report an error

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