FDA 510(k) Physical Medicine Devices
About Physical Medicine Devices
FDA 510(k) physical medicine devices cover therapeutic and diagnostic equipment used in rehabilitation and physical therapy. The FDA review panel code is PM.
Main categories:
- Electrotherapy devices - TENS, NMES, interferential current and iontophoresis
- Ultrasound therapy - therapeutic ultrasound for musculoskeletal conditions
- Phototherapy systems - low-level laser therapy (LLLT) and LED panels
- Diagnostic ultrasound - musculoskeletal and point-of-care ultrasound systems
- Traction and CPM devices - continuous passive motion and mechanical traction
5431
Total
5424
Cleared
115d
Avg days
1976
Since
307 Physical Medicine devices
Cleared
Feb 16, 2019
Wu's Powered Wheelchair
ITI
Wheelchair, Powered
291d
Cleared
Jan 24, 2019
BTL-703
IMJ
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
147d
Cleared
Dec 11, 2018
Invacare TDX SP2-HD with Captain's Seat
ITI
Wheelchair, Powered
49d
Cleared
Nov 14, 2018
Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
IOR
Wheelchair, Mechanical
203d
Cleared
Oct 25, 2018
SLENDERTONE CoreFit Abs 8, Type 734
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
224d
Cleared
Oct 23, 2018
BTL 799-2T
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
81d
Cleared
Jun 14, 2018
BTL 799-2
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
77d
Cleared
May 21, 2018
Erchonia FX-635
NHN
Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
117d
Cleared
Oct 02, 2017
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
IPF
Stimulator, Muscle, Powered
94d
Cleared
Jul 12, 2017
Invacare® TDX® SP2 Power Wheelchair
ITI
Wheelchair, Powered
141d
Cleared
Apr 17, 2017
Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair
IOR
Wheelchair, Mechanical
209d
Cleared
Feb 16, 2017
AM-100
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
98d
Cleared
Dec 28, 2016
Kuschall Champion Manual Wheelchair
IOR
Wheelchair, Mechanical
92d
Cleared
Dec 28, 2016
Kuschall K-Series Attract Manual Wheelchair
IOR
Wheelchair, Mechanical
92d
Cleared
Dec 28, 2016
Kuschall Advance Manual Wheelchair
IOR
Wheelchair, Mechanical
92d
Cleared
Nov 01, 2016
SLENDERTONE® Connect Abs, Type 570
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
106d
Cleared
Oct 21, 2016
HPM-6000
IPF
Stimulator, Muscle, Powered
196d
Cleared
Mar 18, 2016
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
MPO
Infant Heel Warmer (chemical Heat Pack)
255d
Cleared
Feb 18, 2016
Erchonia EVRL
NHN
Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
197d
Cleared
Jan 05, 2016
MyOn HC Manual Wheelchair
IOR
Wheelchair, Mechanical
123d
Cleared
Jan 04, 2016
Erchonia PL Touch
NHN
Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
76d
Cleared
Nov 25, 2015
HEARTWAY Power Mobility Scooter
INI
Vehicle, Motorized 3-wheeled
159d
Cleared
Nov 13, 2015
BTL-4000
IMG
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
275d
Cleared
Nov 13, 2015
ComboRehab
IMG
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
267d
Cleared
Nov 06, 2015
Slendertone connect Abs
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
119d
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