| Proprietary Name: |
01-FIN189-LXL MCDAVID Ankle X Replacement Liner - Small/Medium; 01-FIN189-SMD MCDAVID Ankle X Replacement Liner - Large/XL; 191R-B MCDAVID Level 2 Ankle Support w/ straps & stays - Black - One Size; 431R-BS-L MCDAVID Level 1 Ankle Sleeve - Black - Large; 431R-BS-M MCDAVID Level 1 Ankle Sleeve - Black - Medium; 431R-BS-S MCDAVID Level 1 Ankle Sleeve - Black - Small; 431R-BS-XL MCDAVID Level 1 Ankle Sleeve - Black - XL; 432R-B-L MCDAVID Level 2 Ankle Support w/ figure-8 straps - Black - Large; 432R-B-M MCDAVID Level 2 Ankle Support w/ figure-8 straps - Black - Medium; 432R-B-S MCDAVID Level 2 Ankle Support w/ figure-8 straps - Black - Small; 432R-B-XL MCDAVID Level 2 Ankle Support w/ figure-8 straps - Black - XL; 433R-M MCDAVID Level 2 Ankle Support / mesh w/ straps - White - Medium; 436R-L/XL MCDAVID Level 2 Achilles Tendon Support - Black - Large/XL; 436R-S/M MCDAVID Level 2 Achilles Tendon Support - Black - Small/Medium; 438R MCDAVID Level 1 Ankle Wrap / adjustable - Black - One Size; 5115R-B-L MCDAVID Level 2 Ankle Sleeve / 4-way elastic w/ gel buttresses - Black - Large; 5115R-B-M MCDAVID Level 2 Ankle Sleeve / 4-way elastic w/ gel buttresses - Black - Medium; 5115R-B-S MCDAVID Level 2 Ankle Sleeve / 4-way elastic w/ gel buttresses - Black - Small; 5115R-B-XL MCDAVID Level 2 Ankle Sleeve / 4-way elastic w/ gel buttresses - Black - XL; 511R-L MCDAVID Level 1 Ankle Sleeve / elastic - Black - Large; 511R-M MCDAVID Level 1 Ankle Sleeve / elastic - Black - Medium; 511R-S MCDAVID Level 1 Ankle Sleeve / elastic - Black - Small; 511R-XL MCDAVID Level 1 Ankle Sleeve / elastic - Black - XL; 5122-BK-L MCDAVID Ankle Sleeve / 4-way elastic w/ figure-8 straps - Black - Large; 5122-BK-M MCDAVID Ankle Sleeve / 4-way elastic w/ figure-8 straps - Black - Medium; 5122-BK-S MCDAVID Ankle Sleeve / 4-way elastic w/ figure-8 straps - Black - Small; 5122-BK-XL MCDAVID Ankle Sleeve / 4-way elastic w/ figure-8 straps - Black - XL; MD195 Ankle Brace w/ Straps; MD199 Ankle Brace / Lace-up w/ Stays; MD30190 Reflect Infrared Recovery Compression Ankle Sleeve; MD30930 Neoprene Ankle Support; MD431 Ankle Sleeve; MD432 Ankle Support w/ figure-8 straps; MD511 Ankle Sleeve/elastic; MD5115 Ankle Sleeve/4-way elastic w/ gel buttresses; MD5121 Ankle Sleeve 4-Way Elastic; MD5122 Ankle Sleeve/4-way elastic w/ figure-8 straps; MDA101 Ankle Brace / Lace-up w/ inserts; MDS1112 Ankle Sleeve with Wrap Support; MDS1122 McDavid Sport Ankle Knit Sleeve; SD172 Ankle Compression Wrap; SD175 Ankle Support w/ Fig 8 Strap; SD40480 Ankle Sleeve; SD40820 Ankle Sleeve; SD40820 Ankle Sleeve Yth |
| Classification Name: |
JOINT, ANKLE, EXTERNAL BRACE |
| Product Code: |
ITW |
| Device Class: |
1 |
| Regulation Number: |
890.3475 |
| Medical Specialty: |
Physical Medicine |
| Registered Establishment Name: |
CR UNO INDUSTRIAL CO. LTD
|
| Registered Establishment Number: |
3008520652
|
| Owner/Operator: |
CR UNO Industrial Co. LTD |
| Owner/Operator Number: |
10033413
|
| Establishment Operations: |
Contract Manufacturer; Manufacturer
|
