FDA Registration
Active
🇺🇸 United States
L6 - Perseus, L7 - Cobra, L8 - DAS, LP L9 - Coleman, LP M1 - Field, M2 - Garrison, M3 - Leisure
Reg #: 3021443431
·
FEI: 3021443431
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Expires 2025
Products
1
Proprietary Names
22
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KEVINROOT MEDICAL
- Registration Number
- 3021443431
- FEI Number
- 3021443431
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2239 Business Way
- City
- Riverside
- State
- CA
- ZIP
- 92501
- Country
- US
Owner / Operator
- Firm Name
- KevinRoot Medical
- Operator Number
- 10091892
- Address
- 2239 Business Way
- City
- Riverside
- State
- CA
- Postal Code
- 92501
- Country
- US
- Correspondent
- Kevin Rosenbloom
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2024-11-13 |
Proprietary Names
L6 - Perseus, L7 - Cobra, L8 - DAS, LP L9 - Coleman, LP M1 - Field, M2 - Garrison, M3 - Leisure
Root SSC, Root Women's Casual, Root Women's High-Heel
S16 - Road Cycling, S17 - Mountain Biking, S18 Trail Running, S19 - Figure Skating, S2 Ski Pro
A9 - Coleman, Carbon Footplate Rigid, Carbon Footplate Semi-Rigid, CE - Control EVA, CP - Control Polypro
S20 - Ice/Roller Hockey S21 - Hunting & Fishing, S22 - Hiker, S23 - Ultralite Runner, S3 - Snowboard, S4 - Basketball
Root Multi-Sport-Plus, Root PolyMax, Root Polypropylene, Root Polypropylene, Root Soft-Sport, Root Soft-Sport-Flex
T7-A5514 Therapeutic Shoe UCB Type Orthosis
3D Design Only, A1 - Pro Sport ,A10 - Easy Flex, A100 - Solid Ankle ,A11 - Cushion Plus
Root Fiberglass, Root Graphite, Root Hole-Heel, Root Men's Dress, Root Modified UCBL, Root Multi-Sport
PP - Performance Polypro, PT - Performance TL Carbon, PX - Performance XT Carbon, Root Acrylic, Root Blake, Root Cobra
T9 - EVA UCBL, UE- UCBL fit EVA, UP- UCBL fit Polypro, UT- UCBL fit TL Carbon, UX- UCBL fit XT Carbon, Clips and Zip
P6 - Heel Spurs, P7 - Intoeing Gait , P8 - Metatarsalgia, P9 - Neuroma, PE - Performance EVA
T1 - Care Soft, T2 - Care Firm, T3 - Premium Diabetic, T4 - UCBL, T5 - Modified UCBL, T6 - Pediatric UCBL
P1 - Achilles Tendinopathy, P10 - Pediatric Flatfoot, P11 - Pes Cavus, P12 - Pes Planus, P13 - Plantar Fasciitis
T7.1 -Diabetic Inserts 1 Pr, 2, 3 prs, T7.1- Diabetic Inserts w/ Bilateral Filler T7.1- Diabetic Inserts w/ Unilateral
Root Cushion-Flex, Root Cushion-Flex-Control, Root Diaba-Flex, Root Diaba-Flex-Control, Root Dwyer
L1 - Fashion, L10 - High Heels, L2 - Princess, L3 - Ultra Slim, L4 - SuboFlex LP, L5 - Supporter LP
P14 - Sesamoiditis, P2 - Adult Acquired Flatfoo,t P3 - Lateral Ankle Instability, P4 - Hallux Limitus, P5 - Hallux Rigid
A12 - Unit A2 - Carbon Sport, A3 - Classic Sport ,A4 - Subo-Flex, A5 - Supporter ,A6 - Cork & Leather, A7 - Pro EVA A8
S1 - Ski, S10 - Volleyball, S11 - Tennis, S12 - Water, S13 - Skateboard, S14 - Track & Field, S15 - Golf
CT - Control TL Carbon, CX - Control ,XT Carbon, DP - Dress Polypro, DT - Dress TL Carbon, DX - Dress XT Carbon
S4.5 - Basketball Equipe, S5 - Football, S5.5 Lineman, S6 - Baseball, S7 - Soccer, S8 - Jogging, S9 - Marathon
Establishment Types
Manufacture Medical Device