Turtlebrace

This is a finger add-on for the Turtlebrace wrist brace. It can also be used as a toe extension for the Turtlebrace ankle brace. It is composed of a low-temperature thermoplastic fused…

Registry build 21.09.26

This is a finger add-on for the Turtlebrace wrist brace. It can also be used as a toe extension for the Turtlebrace ankle brace. It is composed of a low-temperature thermoplastic fused between a layer of 3D stretchable knitted fabric and a layer of 3D stretchable knitted velcro receptive fabric. The add-on is fused to the brace and then can be molded directly to the patient, to immobilize one or more fingers, with the ability to be remolded to follow the patient’s change in morphology (loss of swelling), evolution in a treatment (tendon stretching for toe walkers), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size Universal

144manufacturers in China registered for this device type
17catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (46), Zhejiang (25), Jiangsu (20). 32 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IQI
Manufacturer City Province Registered as Device types
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
Suzhou Sunmed Co., Ltd. Suzhou Jiangsu Contract manufacturer 28
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Fortune Company Ltd. Huizhou Guangdong Contract manufacturer 23
Allmay Bodywear (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 21
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Anji Hengfeng Sanitary Material Co., Ltd. Anji Zhejiang Contract manufacturer 20
Wellpower Sporting Goods Co., Ltd. Dong Guan Guangdong Contract manufacturer 18
Anhui Kangfu Industrial Foreign Trade Co., Ltd. Tianchang Anhui Contract manufacturer 18
Metacare Industrial Ltd Guangzhou Guangdong Contract manufacturer 17

Showing 12 of 144. All 144 manufacturers in China registered for Orthosis, Limb Brace

Record

Regulatory record for Turtlebrace
Listed by 9321-8758 Québec Inc
FDA product code IQI
Device type Orthosis, Limb Brace
Device class Class 1
Regulation 21 CFR 890.3475
Premarket notification Exempt
Record published 2023-01-16

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Turtlebrace
Catalogue number Size Status
Elbow Adult ADU S for adult small In distribution
Wrist Adult with velcro closure ADU S for Adult Small In distribution
Ankle Pediatric PED S for Pediatric Small In distribution
Ankle Adult ADU S for adult small In distribution
Wrist Pediatric with zipper closure PED M for Pediatric Medium In distribution
Universal Finger Unvsl for Universal In distribution
Ankle Adult Reinforced ADU S for adult small In distribution
Wrist Pediatric with velcro closure PED M for Pediatric Medium In distribution
Ankle Baby BB S for Baby Small In distribution
Wrist Adult with zipper closure ADU S for Adult Small In distribution
Ankle Pediatric Reinforced PED M for pediatric medium In distribution
Universal Fingers Attachement Unvsl for Universal In distribution
Universal Thumb Attachement Unvsl for Universal In distribution
Elbow Pediatric PED S for pediatric small In distribution
Elbow Baby BB S for baby small In distribution
Wrist Adult ADU S for Adult Small In distribution
Wrist Pediatric PED M for Pediatric Medium In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medi Medi Manufacturing Inc 984
DeRoyal Deroyal Industries, Inc. 295
Thrive Orthopedics Thrive Orthopedics 272
Formthotics Foot Science International, Ltd. 254
VQ Orthocare Vision Quest Industries, Inc. 156
Donjoy Performance DJO, LLC 78
Profit Pantymed S.A. 73
Procare DJO, LLC 63
PediHip Orthopediatrics, Corp 60
ComfyHealth Comfy Health Group Co., Ltd. 51
Push braces Nea International B.V. 48
Soft Stride Brownmed 44

Showing 12 of 664. All products under Orthosis, Limb Brace

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer