Panels › Physical Medicine
Physical Medicine devices
187 product codes reviewed by the Physical Medicine panel. 5,674 510(k) clearances and 770 recalls in the FDA data, 35% of those recalls name a 510(k).
136510(k)s in 12 months
50recalls in 12 months
269recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| ITI | Wheelchair, Powered | 71 | 17 |
| IOR | Wheelchair, Mechanical | 40 | 0 |
| IOQ | Bed, Flotation Therapy, Powered | 38 | 3 |
| ITJ | Walker, Mechanical | 29 | 2 |
| IMD | Pack, Hot Or Cold, Disposable | 26 | 0 |
| INM | Chair, With Casters | 25 | 0 |
| IRT | Pad, Heating, Powered | 24 | 1 |
| INN | Chair, Adjustable, Mechanical | 23 | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 22 | 4 |
| INI | Vehicle, Motorized 3-Wheeled | 22 | 0 |
| IKX | Aid, Transfer | 20 | 0 |
| ILY | Lamp, Infrared, Therapeutic Heating | 20 | 2 |
| ILQ | System, Communication, Powered | 19 | 2 |
| IOL | Treadmill, Powered | 19 | 0 |
| IQA | System, Environmental Control, Powered | 17 | 2 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| ITI | Wheelchair, Powered | 2 | 43 | 17 |
| INI | Vehicle, Motorized 3-Wheeled | 2 | 24 | 0 |
| IOR | Wheelchair, Mechanical | 1 | 20 | 0 |
| IRP | Massager, Powered Inflatable Tube | 2 | 13 | 0 |
| OAP | Laser, Comb, Hair | 2 | 11 | 0 |
| ILJ | Bath, Hydro-Massage | 2 | 0 | 10 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | 6 | 0 |
| ILO | Pack, Hot Or Cold, Water Circulating | 2 | 0 | 4 |
| ILY | Lamp, Infrared, Therapeutic Heating | 2 | 1 | 2 |
| IOQ | Bed, Flotation Therapy, Powered | 2 | 0 | 3 |
| IPF | Stimulator, Muscle, Powered | 2 | 3 | 0 |
| ISA | Massager, Therapeutic, Electric | 1 | 0 | 3 |
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | 2 | 3 | 0 |
| SDO | Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation | 2 | 3 | 0 |
| ILQ | System, Communication, Powered | 2 | 0 | 2 |
| IQA | System, Environmental Control, Powered | 2 | 0 | 2 |
| ITJ | Walker, Mechanical | 1 | 0 | 2 |
| PHL | Powered Exoskeleton | 2 | 2 | 0 |
| SGT | Electromagnetic Stimulator For Healthy Muscle Stimulation | 2 | 2 | 0 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 2 | 1 | 0 |
| IME | Pack, Hot Or Cold, Reusable | 1 | 0 | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 2 | 1 | 0 |
| INN | Chair, Adjustable, Mechanical | 1 | 0 | 1 |
| IRT | Pad, Heating, Powered | 2 | 0 | 1 |
| ITG | Bandage, Cast | 1 | 0 | 1 |
| KNN | Components, Wheelchair | 1 | 0 | 1 |
| OSD | Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature | 2 | 1 | 0 |
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | 2 | 1 | 0 |
| QYN | Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use) | 1 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2026 | Medline Industries, LP Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS Open, Classified |
ITJ | None listed |
| Oct 5, 2026 | Medline Industries, LP Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XW Open, Classified |
ITJ | None listed |
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient move Open, Classified |
IOQ | None listed |
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient move Open, Classified |
IOQ | None listed |
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a pa Open, Classified |
IOQ | None listed |
| Aug 14, 2026 | Tobii Dynavox Llc TD Navio Maxi Speech Generating Device
Model/Catalog Number: 1000799 Open, Classified |
ILQ | None listed |
| Aug 14, 2026 | Tobii Dynavox Llc TD Navio Midi Speech Generating Device
Model/Catalog Number: 1000798 Open, Classified |
ILQ | None listed |
| Jul 31, 2026 | MUNEVO GMBH munevo DRIVE and munevo DRIVE r-net
Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System Open, Classified |
KNN | None listed |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum Rival
Model/Catalog Number: Quantum Rival
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Compone Open, Classified |
ITI | K011993 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: 4Front
Model/Catalog Number: 4Front
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Controller Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum 4Front 2HD
Model/Catalog Number: Quantum 4Front 2HD
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.38 Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Q6 Edge 4
Model/Catalog Number: Q6 Edge 4
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Cont Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Q6 Edge 3
Model/Catalog Number: Q6 Edge 3
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Cont Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Q6 Edge 2.0 (ilevel)
Model/Catalog Number: Q6 Edge 2.0 (ilevel)
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 89 Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum 1450
Model/Catalog Number: Quantum 1450
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component Open, Classified |
ITI | K112815 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum rehab
Product Name: Q6 Edge 2.0
Model/Catalog Number: Q6 Edge 2.0
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Open, Classified |
ITI | K042612 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Q6 Edge HD
Model/Catalog Number: Q6 Edge HD
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Co Open, Classified |
ITI | K042612 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: R-TRAK
Model/Catalog Number: R-TRAK
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component: Controller Open, Classified |
ITI | K011993 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Q6 Edge 3 Stretto
Model/Catalog Number: Q6 Edge 3 Stretto
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860 Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum Outback
Model/Catalog Number: Quantum Outback
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Com Open, Classified |
ITI | K112815 |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum 4Front 2
Model/Catalog Number: Quantum 4Front 2
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
C Open, Classified |
ITI | K143383 |
| Jul 31, 2026 | Therabody, Inc Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger.
G4 PRO Black US - Refurb., SKU TG02428-01
G4 PRO NA, SKU G4-PRO-PKG-NA
Open, Classified |
ISA | None listed |
| Jul 24, 2026 | Permobil Inc Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock
REF:120031, Model version 3 Open, Classified |
ITI | K123290 |
| Jul 24, 2026 | Permobil Inc M5 Corpus Power Wheelchair REF,120032 Open, Classified |
ITI | K123290 |
| Jun 17, 2026 | MITO RED LIGHT INC Mito Red Light, Super Mobile Open, Classified |
ILY | None listed |
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