FDA Registration
Active
🇹🇼 Taiwan
404R-BS-L MCDAVID Level 1 Knee Sleeve w/ anterior patch & open patella - Black - Large
Reg #: 3008520652
·
FEI: 3008520652
·
Expires 2025
Products
1
Proprietary Names
150
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CR UNO INDUSTRIAL CO. LTD
- Registration Number
- 3008520652
- FEI Number
- 3008520652
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 23, Ln 1005, Sec 1, Hemu Rd., Qing Shui District
- City
- Taichung City, Taiwan
- Country
- TW
Owner / Operator
- Firm Name
- CR UNO Industrial Co. LTD
- Operator Number
- 10033413
- Address
- No. 1-23 Chou Zang Rd, Hi-Feng Li
- City
- Chin Swea
- State
- Taichung
- Postal Code
- --
- Country
- TW
US Agent
- Business Name
- CR UNO INDUSTRIAL CO. LTD
- Contact Name
- Ray White
- Address
- 6719 Seton House Ln
- City
- Charlotte
- State
- NC
- ZIP
- 28277
- Country
- US
- [email protected]
- Phone
- 704 8985198
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2010-11-11 |
Proprietary Names
404R-BS-L MCDAVID Level 1 Knee Sleeve w/ anterior patch & open patella - Black - Large
404R-BS-XXL MCDAVID Level 1 Knee Sleeve w/ anterior patch & open patella - Black - 2XL
421T-BL-L MCDAVID Level 2 Knee Support w/ stays - Black - Large
4192R-M MCDAVID Level 2 Knee Support / double wrap - Black - Medium
429R-BL-XL MCDAVID Level 3 Knee Brace w/ polycentric hinges - Black - XL
421R-BL-L MCDAVID Level 2 Knee Support w/ stays - Black - Large
421T-BL-XL MCDAVID Level 2 Knee Support w/ stays - Black - XL
4195R-B-L MCDAVID Level 2 Knee Support / adjustable / cross straps - Black - Large
510R-M MCDAVID Level 1 Knee Sleeve / elastic - Black - Medium
427T-BL-L MCDAVID Level 3 Knee Brace w/ hyper-extension hinges & straps - Black - Large
403R-BS-S MCDAVID Level 1 Knee Sleeve w/ anterior patch - Black - Small
414R-R MCDAVID Level 2 Knee Strap / patella - Royal - One Size
425T-BL-XL MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - XL
404R-BS-S MCDAVID Level 1 Knee Sleeve w/ anterior patch & open patella - Black - Small
429R-BL-L MCDAVID Level 3 Knee Brace w/ polycentric hinges - Black - Large
403R-BS-M MCDAVID Level 1 Knee Sleeve w/ anterior patch - Black - Medium
421R-BL-S MCDAVID Level 2 Knee Support w/ stays - Black - Small
421R-BL-XL MCDAVID Level 2 Knee Support w/ stays - Black - XL
401R-BS-M MCDAVID Level 1 Knee Sleeve - Black - Medium
402R-BS-XL MCDAVID Level 1 Knee Support w/ open patella - Black - XL
401T-BS-XL MCDAVID Level 1 Knee Sleeve - Black - XL
410R-BS-S MCDAVID Level 1 Knee Support w/ Sorbothane pad - Black - Small
425R-BL-XXL MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - 2XL
4192R-L MCDAVID Level 2 Knee Support / double wrap - Black - Large
429R-BL-S MCDAVID Level 3 Knee Brace w/ polycentric hinges - Black - Small
408R MCDAVID Level 1 Knee Wrap / adjustable - Black - One Size
425T-BL-XXL MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - 2XL
5125R-B-XL MCDAVID Level 2 Knee Sleeve / 4-way elastic w/ gel buttress - Black - XL
401R-BS-S MCDAVID Level 1 Knee Sleeve - Black - Small
402R-BS-XXL MCDAVID Level 1 Knee Support w/ open patella - Black - 2XL
425R-BL-XL MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - XL
401R-BS-XXL MCDAVID Level 1 Knee Sleeve - Black - 2XL
404R-BS-XL MCDAVID Level 1 Knee Sleeve w/ anterior patch & open patella - Black - XL
402T-BS-M MCDAVID Level 1 Knee Support w/ open patella - Black - Medium
401T-BS-S MCDAVID Level 1 Knee Sleeve - Black - Small
427T-BL-XXL MCDAVID Level 3 Knee Brace w/ hyper-extension hinges & straps - Black - 2XL
419R-S/M MCDAVID Level 2 Knee Support / adjustable - Black - Small/Medium
4195R-B-M MCDAVID Level 2 Knee Support / adjustable / cross straps - Black - Medium
5125R-B-L MCDAVID Level 2 Knee Sleeve / 4-way elastic w/ gel buttress - Black - Large
403R-BS-L MCDAVID Level 1 Knee Sleeve w/ anterior patch - Black - Large
4193-BK MCDAVID Level 2 Iliotibial Band Support - Black - One Size
429RX-B-S MCDAVID Level 3 Knee Brace w/ polycentric hinges & cross straps - Black - Small
425R-BL-S MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Small
421T-BL-S MCDAVID Level 2 Knee Support w/ stays - Black - Small
402R-BS-S MCDAVID Level 1 Knee Support w/ open patella - Black - Small
422R-L MCDAVID Level 3 Knee Brace w/ dual disk hinges - Black - Large
510R-XL MCDAVID Level 1 Knee Sleeve / elastic - Black - XL
428R-BL-XL MCDAVID Level 3 Knee Brace w/ HD polycentric hinges - Black - XL
5125R-B-S MCDAVID Level 2 Knee Sleeve / 4-way elastic w/ gel buttress - Black - Small
4195R-B-S MCDAVID Level 2 Knee Support / adjustable / cross straps - Black - Small
422R-M MCDAVID Level 3 Knee Brace w/ dual disk hinges - Black - Medium
425T-BL-S MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Small
401T-BS-XXL MCDAVID Level 1 Knee Sleeve - Black - 2XL
429RX-B-M MCDAVID Level 3 Knee Brace w/ polycentric hinges & cross straps - Black - Medium
410R-BS-XL MCDAVID Level 1 Knee Support w/ Sorbothane pad - Black - XL
422R-XXL MCDAVID Level 3 Knee Brace w/ dual disk hinges - Black - 2XL
414R-S MCDAVID Level 2 Knee Strap / patella - Scarlet - One Size
429RX-B-XL MCDAVID Level 3 Knee Brace w/ polycentric hinges & cross straps - Black - XL
428R-BL-L MCDAVID Level 3 Knee Brace w/ HD polycentric hinges - Black - Large
425R-BL-L MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Large
421T-BL-M MCDAVID Level 2 Knee Support w/ stays - Black - Medium
427T-BL-S MCDAVID Level 3 Knee Brace w/ hyper-extension hinges & straps - Black - Small
414R MCDAVID Level 2 Knee Strap / patella - Black - One Size
427T-BL-XL MCDAVID Level 3 Knee Brace w/ hyper-extension hinges & straps - Black - XL
429RX-B-XXL MCDAVID Level 3 Knee Brace w/ polycentric hinges & cross straps - Black - 2XL
402T-BS-XXL MCDAVID Level 1 Knee Support w/ open patella - Black - 2XL
5125R-B-M MCDAVID Level 2 Knee Sleeve / 4-way elastic w/ gel buttress - Black - Medium
4192R-S MCDAVID Level 2 Knee Support / double wrap - Black - Small
422R-XL MCDAVID Level 3 Knee Brace w/ dual disk hinges - Black - XL
410R-BS-L MCDAVID Level 1 Knee Support w/ Sorbothane pad - Black - Large
401R-BS-L MCDAVID Level 1 Knee Sleeve - Black - Large
425R-BL-M MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Medium
428R-BL-XXL MCDAVID Level 3 Knee Brace w/ HD polycentric hinges - Black - 2XL
429R-BL-M MCDAVID Level 3 Knee Brace w/ polycentric hinges - Black - Medium
428R-BL-S MCDAVID Level 3 Knee Brace w/ HD polycentric hinges - Black - Small
403R-BS-XL MCDAVID Level 1 Knee Sleeve w/ anterior patch - Black - XL
402T-BS-XL MCDAVID Level 1 Knee Support w/ open patella - Black - XL
414R-GR MCDAVID Level 2 Knee Strap / patella - Gray - One Size
401T-BS-M MCDAVID Level 1 Knee Sleeve - Black - Medium
410R-BS-M MCDAVID Level 1 Knee Support w/ Sorbothane pad - Black - Medium
429RX-B-L MCDAVID Level 3 Knee Brace w/ polycentric hinges & cross straps - Black - Large
421R-BL-XXL MCDAVID Level 2 Knee Support w/ stays - Black - 2XL
427T-BL-M MCDAVID Level 3 Knee Brace w/ hyper-extension hinges & straps - Black - Medium
402R-BS-L MCDAVID Level 1 Knee Support w/ open patella - Black - Large
402T-BS-L MCDAVID Level 1 Knee Support w/ open patella - Black - Large
402R-BS-M MCDAVID Level 1 Knee Support w/ open patella - Black - Medium
421R-BL-M MCDAVID Level 2 Knee Support w/ stays - Black - Medium
421T-BL-XXL MCDAVID Level 2 Knee Support w/ stays - Black - 2XL
429R-BL-XXL MCDAVID Level 3 Knee Brace w/ polycentric hinges - Black - 2XL
422R-S MCDAVID Level 3 Knee Brace w/ dual disk hinges - Black - Small
403R-BS-XXL MCDAVID Level 1 Knee Sleeve w/ anterior patch - Black - 2XL
401R-BS-XL MCDAVID Level 1 Knee Sleeve - Black - XL
425T-BL-M MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Medium
409R MCDAVID Level 1 Knee Wrap / adjustable w/ open patella - Black - One Size
510R-L MCDAVID Level 1 Knee Sleeve / elastic - Black - Large
510R-S MCDAVID Level 1 Knee Sleeve / elastic - Black - Small
401T-BS-L MCDAVID Level 1 Knee Sleeve - Black - Large
425T-BL-L MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Large
5116-BK-S MCDAVID Knee Sleeve / 4-way elastic w/ gel buttress and stays - Black - Small
402T-BS-S MCDAVID Level 1 Knee Support w/ open patella - Black - Small
428R-BL-M MCDAVID Level 3 Knee Brace w/ HD polycentric hinges - Black - Medium
419R-L/XL MCDAVID Level 2 Knee Support / adjustable - Black - Large/XL
404R-BS-M MCDAVID Level 1 Knee Sleeve w/ anterior patch & open patella - Black - Medium
MD421 Knee Support w/ Stays
5116-BK-XL MCDAVID Knee Sleeve / 4-way elastic w/ gel buttes and stays - Black - XL
SD181 Knee Patella Strap
MD4192 Knee Support/double wrap
MD5125 Knee Sleeve/4-way elastic w/ gel buttress
MD401 Knee Sleeve
MD410 Knee Support w/ Sorbothane pad
5116-BK-L MCDAVID Knee Sleeve / 4-way elastic w/ gel buttress and stays - Black - Large
MD419 Knee Support/adjustable
5116-BK-M MCDAVID Knee Sleeve / 4-way elastic w/ gel buttress and stays - Black - Medium
MD5116 Knee Sleeve/4-way elastic w/ gel buttress and stays
SD185 Knee Support w/ Dual Wrap
MD510 Knee Sleeve / elastic
MD414 Knee Strap/patella
MD428 Knee Brace w/ HD polycentric Hinges
MD422 Knee Brace w/ dual disk hinges
MD402 Knee Support w/ open patella
MD403 Knee Sleeve w/ anterior patch
MD429 Knee Brace w/ polycentric hinges
MD4193 Illiotibial Band Support
MD425 Knee Support w/ stays & cross Straps
MD409 Knee Wrap/adjustable w/ open patella
SD182 Knee Compression Sleeve w/ Open Patella
MD4195 Knee Support/adjustable/cross straps
MD429 Knee Brace w/ polycentric hinges & cross straps
MD404 Knee Sleeve w/ anterior patch & open patella
MD4201 VOW Knee Wrap with Stays
MD4203 VOW Knee Wrap with Stays & Straps
MD5113 Knee Sleeve 4-Way Elastic
MDX801 Dual Density Knee Support Sleeves
882 Quick-On Knee Stabilizer with Versatile Over Wrap System & Flexible Support Stays
884 Quick-On Knee Stabilizer with Versatile Over Wrap System & Flexible Support Stays/Straps
880 Quick-On Knee Support with Versatile Over Wrap System
MD4205 VOW Knee Wrap with Hinges & Straps
886 Quick-On Knee Stabilizer with Versatile Over Wrap System & Bilateral Hinges/Straps
MDP420 Neoprene Dual Wrap Knee Support w/ Abrasion Patch
MDS1226 McDavid Sport Knee Knit Sleeve with Buttress and Stays
MDS1112 Ankle Sleeve with Wrap Support
MDS1217 Knee Patella Support Wrap with Dual Straps
MDS1224 McDavid Sport Knee Knit Sleeve with Gel Buttress
MDP400 Neoprene Knee Sleeve w/ Abrasion Patch
MDS1217 Knee Patella Support Wrap w/ Dual Straps
MDS1214 Knee Sleeve with Open Patella
MDS1216 Knee Sleeve with Open Patella
SD40460 Knee Sleeve
MD30150 Reflect Infrared Recovery Compression Knee Sleeve
SD40920 Reflect Infrared Rec Comp Knee Sleeve
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device