Part 890 Subpart F—Physical Medicine Therapeutic Devices
FDA submissions for Part 890 Subpart F—Physical Medicine Therapeutic Devices in the Physical Medicine (PM) review panel, including product codes and regulations.
Section range: §§ 890.5050–890.5975
CFR Part: 890
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| 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 |
