Part 890 Subpart D—Physical Medicine Prosthetic Devices
FDA submissions for Part 890 Subpart D—Physical Medicine Prosthetic Devices in the Physical Medicine (PM) review panel, including product codes and regulations.
Section range: §§ 890.3025–890.3940
CFR Part: 890
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| IPG | Shoe, Cast | 890.3025 | 1 | 6 |
| IPM | Cover, Limb | 890.3025 | 1 | 6 |
| IQM | Splint, Temporary Training | 890.3025 | 1 | 3 |
| IQO | Device, Prosthesis Alignment | 890.3025 | 1 | 0 |
| IQP | Rotator, Transverse | 890.3025 | 1 | 1 |
| ISM | Pylon, Post Surgical | 890.3025 | 1 | 0 |
| ISR | Band Or Belt, Pelvic Support | 890.3025 | 1 | 1 |
| ITG | Bandage, Cast | 890.3025 | 1 | 37 |
| NDA | Helmet, Cranial, For Protective Use | 890.3025 | 1 | 0 |
| NHF | Monitor, Orthotic/Prosthetic | 890.3025 | 1 | 0 |
| IPS | Cane | 890.3075 | 1 | 9 |
| KHY | Cane, Safety Walk | 890.3075 | 1 | 0 |
| INM | Chair, With Casters | 890.3100 | 1 | 35 |
| INN | Chair, Adjustable, Mechanical | 890.3100 | 1 | 26 |
| INO | Chair, Positioning, Electric | 890.3110 | 2 | 53 |
| IPR | Crutch | 890.3150 | 1 | 4 |
| KIC | Cushion, Flotation | 890.3175 | 1 | 29 |
| ITC | Stirrup, External Brace Component | 890.3410 | 1 | 0 |
| ITO | Twister, Brace Setting | 890.3410 | 1 | 1 |
| IQQ | Joint, Shoulder, External Limb Component | 890.3420 | 1 | 0 |
| IQW | Hook, External Limb Component, Powered | 890.3420 | 1 | 0 |
| IQX | Hook, External Limb Component, Mechanical | 890.3420 | 1 | 1 |
| IQZ | Hand, External Limb Component, Powered | 890.3420 | 1 | 0 |
| IRA | Hand, External Limb Component, Mechanical | 890.3420 | 1 | 2 |
| IRD | Joint, Elbow, External Limb Component, Mechanical | 890.3420 | 1 | 0 |
| IRE | Joint, Elbow, External Limb Component, Powered | 890.3420 | 1 | 2 |
| ISH | Component, External, Limb, Ankle/Foot | 890.3420 | 1 | 4 |
| ISL | Joint, Hip, External Limb Component | 890.3420 | 1 | 0 |
| ISN | Cable | 890.3420 | 1 | 0 |
| ISP | Valve, Prosthesis | 890.3420 | 1 | 1 |
| ISS | Prosthesis, Thigh Socket, External Component | 890.3420 | 1 | 1 |
| ISY | Joint, Knee, External Limb Component | 890.3420 | 1 | 1 |
| ISZ | Unit, Wrist, External Limb Component, Mechanical | 890.3420 | 1 | 0 |
| KFT | Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical | 890.3420 | 1 | 0 |
| KFW | Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered | 890.3420 | 1 | 0 |
| KGH | Unit, Wrist, External Limb Component, Powered | 890.3420 | 1 | 0 |
| PAE | Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography | 890.3450 | 2 | 1 |
| ILE | Sling, Arm, Overhead Supported | 890.3475 | 1 | 3 |
| ILG | Stocking, Elastic | 890.3475 | 1 | 8 |
| ILH | Splint, Hand, And Components | 890.3475 | 1 | 36 |
| IOY | Support, Arm | 890.3475 | 1 | 1 |
| IQI | Orthosis, Limb Brace | 890.3475 | 1 | 52 |
| ITM | Cage, Knee | 890.3475 | 1 | 5 |
| ITQ | Joint, Knee, External Brace | 890.3475 | 1 | 15 |
| ITS | Joint, Hip, External Brace | 890.3475 | 1 | 1 |
| ITW | Joint, Ankle, External Brace | 890.3475 | 1 | 1 |
| KNP | Orthosis, Corrective Shoe | 890.3475 | 1 | 7 |
| LQX | Device, Finger-Sucking | 890.3475 | 1 | 2 |
| MNE | Orthosis, Moldable, Supportive, Skin Protective | 890.3475 | 1 | 2 |
| OHI | Orthosis, Foot Drop | 890.3475 | 1 | 1 |
| PMV | Orthosis, Limb, For Back Pain | 890.3475 | 1 | 1 |
| QDT | Shoe With Adjustable Sole Units | 890.3475 | 1 | 1 |
| PHL | Powered Exoskeleton | 890.3480 | 2 | 24 |
| IPT | Orthosis, Thoracic | 890.3490 | 1 | 5 |
| IPW | Orthosis, Sacroiliac, Soft | 890.3490 | 1 | 1 |
| IPX | Orthosis, Rib Fracture, Soft | 890.3490 | 1 | 3 |
| IPY | Orthosis, Lumbo-Sacral | 890.3490 | 1 | 11 |
| IQE | Orthosis, Lumbar | 890.3490 | 1 | 4 |
| IQF | Orthosis, Cervical-Thoracic, Rigid | 890.3490 | 1 | 7 |
| IQJ | Splint, Clavicle | 890.3490 | 1 | 4 |
| IQK | Orthosis, Cervical | 890.3490 | 1 | 27 |
| KTD | Orthosis, Abdominal | 890.3490 | 1 | 3 |
| MRI | Orthosis, Truncal/Orthosis, Limb | 890.3490 | 1 | 2 |
| NJB | Orthosis, Truncal, For Dysmenorrhea | 890.3490 | 1 | 1 |
| QSB | Orthosis, Truncal, Pregnancy | 890.3490 | 1 | 1 |
| ISW | Assembly, Knee/Shank/Ankle/Foot, External | 890.3500 | 2 | 1 |
| KFX | Assembly, Thigh/Knee/Shank/Ankle/Foot, External | 890.3500 | 2 | 4 |
| INT | Plinth | 890.3520 | 1 | 4 |
| IPO | Orthosis, Pneumatic Structure, Rigid | 890.3610 | 3 | 0 |
| ILI | Sling, Arm | 890.3640 | 1 | 21 |
| IOZ | Splint, Abduction, Congenital Hip Dislocation | 890.3665 | 1 | 4 |
| ITN | Splint, Denis Brown | 890.3675 | 1 | 3 |
| INK | Stretcher, Wheeled, Powered | 890.3690 | 2 | 12 |
| ILP | System, Communication, Non-Powered | 890.3700 | 1 | 21 |
| ILQ | System, Communication, Powered | 890.3710 | 2 | 38 |
| IQA | System, Environmental Control, Powered | 890.3725 | 2 | 24 |
| INW | Table, Mechanical | 890.3750 | 1 | 35 |
| INQ | Table, Powered | 890.3760 | 1 | 102 |
| SEC | Wearable Fall Injury Prevention Device | 890.3780 | 2 | 1 |
| INP | Tips And Pads, Cane, Crutch And Walker | 890.3790 | 1 | 8 |
| INI | Vehicle, Motorized 3-Wheeled | 890.3800 | 2 | 344 |
| ITJ | Walker, Mechanical | 890.3825 | 1 | 14 |
| NXE | Walker, Mechanical, Poly Vinyl Chloride (Pvc) | 890.3825 | 1 | 1 |
| IOR | Wheelchair, Mechanical | 890.3850 | 1 | 454 |
| LBE | Stroller, Adaptive | 890.3850 | 1 | 8 |
| ITI | Wheelchair, Powered | 890.3860 | 2 | 575 |
| IQC | Wheelchair, Special Grade | 890.3880 | 2 | 24 |
| IMK | Wheelchair, Stair Climbing | 890.3890 | 2 | 5 |
| IPL | Wheelchair, Standup | 890.3900 | 2 | 66 |
| IMS | Support, Head And Trunk, Wheelchair | 890.3910 | 1 | 0 |
| IMX | Board, Lap, Wheelchair | 890.3910 | 1 | 2 |
| IMY | Armboard, Wheelchair | 890.3910 | 1 | 0 |
| IMZ | Holder, Crutch And Cane, Wheelchair | 890.3910 | 1 | 0 |
| INC | Cuff, Pusher, Wheelchair | 890.3910 | 1 | 0 |
| INE | Sling, Overhead Suspension, Wheelchair | 890.3910 | 1 | 1 |
| KID | Restraint, Wheelchair, Non-Protective | 890.3910 | 1 | 7 |
| KNO | Accessories, Wheelchair | 890.3910 | 1 | 35 |
| IML | Armrest, Wheelchair | 890.3920 | 1 | 0 |
| IMM | Footrest, Wheelchair | 890.3920 | 1 | 2 |
| IMN | Climber, Curb, Wheelchair | 890.3920 | 1 | 0 |
| IMO | Handrim, Wheelchair | 890.3920 | 1 | 0 |
| IMP | Cushion, Wheelchair | 890.3920 | 1 | 2 |
| IMQ | Attachment, Narrowing, Wheelchair | 890.3920 | 1 | 0 |
| IMR | Device, Anti-Tip, Wheelchair | 890.3920 | 1 | 0 |
| IMW | Brake, Extension, Wheelchair | 890.3920 | 1 | 0 |
| INA | Hill Holder, Wheelchair | 890.3920 | 1 | 0 |
| INB | Attachment, Commode, Wheelchair | 890.3920 | 1 | 0 |
| IQB | Belt, Wheelchair | 890.3920 | 1 | 2 |
| KNN | Components, Wheelchair | 890.3920 | 1 | 64 |
| LFF | Unit, Activation, Breath Control | 890.3920 | 1 | 1 |
| ING | Elevator, Wheelchair, Portable | 890.3930 | 2 | 29 |
| PCE | Permanently Mounted Wheelchair Platform Lift | 890.3930 | 2 | 1 |
| INF | Scale, Platform, Wheelchair | 890.3940 | 1 | 5 |
