Physical Medicine (PM) FDA Submissions
Browse FDA 510(k), De Novo, and PMA medical device clearances for the Physical Medicine (PM) review panel, including product codes, regulations, and cleared devices.
CFR Parts: Part 882, Part 890
Subparts
- Part 882 Subpart F—Neurological Therapeutic Devices — 1 product code
- Part 890 Subpart B—Physical Medicine Diagnostic Devices — 13 product codes
- Part 890 Subpart D—Physical Medicine Prosthetic Devices — 113 product codes
- Part 890 Subpart F—Physical Medicine Therapeutic Devices — 93 product codes
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| OVP | Vibratory Counter-Stimulation | 882.5895 | 2 | 1 |
| IKD | Cable, Electrode | 890.1175 | 2 | 6 |
| IKP | Chronaximeter | 890.1225 | 2 | 0 |
| IKN | Electromyograph, Diagnostic | 890.1375 | 2 | 75 |
| KZM | Device, Muscle Monitoring | 890.1375 | 2 | 19 |
| OAL | Exercise Equipment, Powered, Emg-Triggered | 890.1375 | 2 | 1 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 890.1385 | 2 | 43 |
| IKO | Hammer, Reflex, Powered | 890.1450 | 2 | 1 |
| KHX | Platform, Force-Measuring | 890.1575 | 1 | 15 |
| JFC | System, Pressure Measurement, Intermittent | 890.1600 | 1 | 11 |
| IKE | Transducer, Miniature Pressure | 890.1615 | 1 | 15 |
| LYH | Arthrometer | 890.1615 | 1 | 5 |
| ISB | Stimulator, Muscle, Diagnostic | 890.1850 | 2 | 5 |
| IKK | System, Isokinetic Testing And Evaluation | 890.1925 | 2 | 61 |
| 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 | 343 |
| 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 | 574 |
| 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 |
| IKW | Utensil, Homemaking | 890.5050 | 1 | 12 |
| IKX | Aid, Transfer | 890.5050 | 1 | 18 |
| ILC | Utensil, Eating | 890.5050 | 1 | 32 |
| ILD | Adaptor, Dressing | 890.5050 | 1 | 14 |
| ILS | Adaptor, Hygiene | 890.5050 | 1 | 31 |
| ILT | Adaptor, Recreational | 890.5050 | 1 | 7 |
| ILW | Adaptor, Grooming | 890.5050 | 1 | 7 |
| IQG | Adaptor, Holder, Syringe | 890.5050 | 1 | 3 |
| NXB | Dispenser, Solid Medication | 890.5050 | 1 | 3 |
| NXQ | Reminder, Medication | 890.5050 | 1 | 2 |
| OAG | Garment, Storage, Peritoneal Dialysis Catheter | 890.5050 | 1 | 0 |
| OIZ | Foot Examination Tool For Inflammatory Changes | 890.5050 | 1 | 2 |
| OJL | Insulin Vial Protector/Holder | 890.5050 | 1 | 0 |
| PCM | Portable Liquid Oxygen Unit Stand | 890.5050 | 1 | 1 |
| QTC | Adult Portable Bed Rails For Medical Purposes | 890.5050 | 1 | 0 |
| ILJ | Bath, Hydro-Massage | 890.5100 | 2 | 73 |
| ILM | Bath, Sitz, Powered | 890.5100 | 2 | 2 |
| LSB | Unit, Fluidotherapy | 890.5100 | 2 | 4 |
| IMC | Bath, Paraffin | 890.5110 | 2 | 12 |
| KTC | Bath, Sitz, Nonpowered | 890.5125 | 1 | 7 |
| ILK | Transport, Patient, Powered | 890.5150 | 2 | 36 |
| PCD | Powered Stairway Chair Lift | 890.5150 | 2 | 0 |
| INX | Bed, Air Fluidized | 890.5160 | 2 | 28 |
| IOQ | Bed, Flotation Therapy, Powered | 890.5170 | 2 | 57 |
| MOC | Cushion, Flotation, Therapeutic | 890.5170 | 2 | 2 |
| INY | Bed, Patient Rotation, Manual | 890.5180 | 1 | 1 |
| IKZ | Bed, Patient Rotation, Powered | 890.5225 | 2 | 17 |
| IMB | Cabinet, Moist Steam | 890.5250 | 2 | 5 |
| HPH | Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat | 890.5275 | 3 | 0 |
| IOA | Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat | 890.5275 | 2 | 4 |
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | 890.5290 | 2 | 15 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 890.5290 | 2 | 44 |
| PQY | Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain | 890.5290 | 2 | 2 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 890.5300 | 2 | 89 |
| LXF | Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat | 890.5300 | 3 | 0 |
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | 890.5300 | 2 | 8 |
| IOD | Components, Exercise | 890.5350 | 1 | 11 |
| ISD | Exerciser, Measuring | 890.5360 | 2 | 61 |
| LXJ | Interactive Rehabilitation Exercise Devices | 890.5360 | 2 | 27 |
| QKC | Interactive Rehabilitation Exercise Device, Prescription Use | 890.5360 | 2 | 0 |
| IOE | Bars, Parallel, Exercise | 890.5370 | 1 | 2 |
| IOG | Treadmill, Mechanical | 890.5370 | 1 | 3 |
| ION | Exerciser, Non-Measuring | 890.5370 | 1 | 43 |
| KNL | Board, Scooter, Prone | 890.5370 | 1 | 5 |
| PKS | Exerciser, Non-Measuring For Stroke Rehabilitation | 890.5370 | 1 | 0 |
| BXB | Exerciser, Powered | 890.5380 | 1 | 160 |
| IOL | Treadmill, Powered | 890.5380 | 1 | 43 |
| IRR | Bars, Parallel, Powered | 890.5380 | 1 | 1 |
| JFA | Exerciser, Finger, Powered | 890.5410 | 1 | 12 |
| ILY | Lamp, Infrared, Therapeutic Heating | 890.5500 | 2 | 229 |
| IOB | Lamp, Infrared, Non Heating | 890.5500 | 2 | 6 |
| LBG | Device, Fluidized Therapy, Dry Heat | 890.5500 | 2 | 1 |
| NHH | Device, Discharge, Electrostatic (For Pain Relief) | 890.5500 | 2 | 2 |
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | 890.5500 | 2 | 53 |
| NZY | Light, Lymphedema Reduction, Low Energy | 890.5500 | 2 | 1 |
| OAP | Laser, Comb, Hair | 890.5500 | 2 | 107 |
| EGJ | Device, Iontophoresis, Other Uses | 890.5525 | 2 | 73 |
| KTB | Device, Iontophoresis, Specific Uses | 890.5525 | 2 | 16 |
| IRN | Device, Warning, Overload, External Limb, Powered | 890.5575 | 2 | 11 |
| IRP | Massager, Powered Inflatable Tube | 890.5650 | 2 | 149 |
| ISA | Massager, Therapeutic, Electric | 890.5660 | 1 | 100 |
| LYG | Massager, Therapeutic, Manual | 890.5660 | 1 | 13 |
| MWZ | Expander, Breast, External | 890.5660 | 1 | 1 |
| OSD | Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature | 890.5670 | 2 | 1 |
| QKD | Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use | 890.5670 | 2 | 0 |
| IME | Pack, Hot Or Cold, Reusable | 890.5700 | 1 | 27 |
| IMD | Pack, Hot Or Cold, Disposable | 890.5710 | 1 | 82 |
| MPO | Infant Heel Warmer (Chemical Heat Pack) | 890.5710 | 1 | 11 |
| OMW | Adhesive Backed Thermal Skin Patches | 890.5710 | 1 | 0 |
| ILO | Pack, Hot Or Cold, Water Circulating | 890.5720 | 2 | 93 |
| IMA | Pack, Heat, Moist | 890.5730 | 1 | 8 |
| IRT | Pad, Heating, Powered | 890.5740 | 2 | 42 |
| OZC | Over The Counter Thermal Treatment For Acne. | 890.5740 | 2 | 1 |
| OTX | Foot Wrap For Treating Restless Leg Syndrome Symptoms | 890.5760 | 1 | 1 |
| KNM | Device, Pressure Applying | 890.5765 | 1 | 2 |
| QYN | Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use) | 890.5775 | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 890.5850 | 2 | 545 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 890.5850 | 2 | 162 |
| NUW | Stimulator, Muscle, Powered, Dental | 890.5850 | 2 | 9 |
| NYY | Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation | 890.5850 | 2 | 0 |
| NYZ | Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning | 890.5850 | 2 | 0 |
| SGT | Electromagnetic Stimulator For Healthy Muscle Stimulation | 890.5850 | 2 | 1 |
| SDO | Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation | 890.5851 | 2 | 3 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 890.5860 | 2 | 55 |
| JFB | Table, Physical Therapy, Multi Function | 890.5880 | 2 | 66 |
| ITH | Equipment, Traction, Powered | 890.5900 | 2 | 71 |
| ILZ | Accessories, Traction | 890.5925 | 1 | 15 |
| IRS | Head Halter, Traction | 890.5925 | 1 | 1 |
| IMF | Unit, Chilling | 890.5940 | 1 | 2 |
| IRQ | Unit, Heating, Powered | 890.5950 | 1 | 7 |
| LHC | Warmer, Irrigation Solution | 890.5950 | 1 | 24 |
| IRO | Vibrator, Therapeutic | 890.5975 | 1 | 65 |
| PHW | Cold Pack And Vibrating Massager | 890.5975 | 1 | 2 |
