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- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- MOCCushion, Flotation, Therapeutic2Product Code
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat2Product Code
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat2Product Code
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat2Product Code
- QOLElectroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser2Product Code
- QRAVirtual Reality Behavioral Therapy Device For Pain Relief2Product Code
- BXBExerciser, Powered1Product Code
- EGJDevice, Iontophoresis, Other Uses2Product Code
- HPHDiathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- IKWUtensil, Homemaking1Product Code
- IKXAid, Transfer1Product Code
- IKZBed, Patient Rotation, Powered2Product Code
- ILCUtensil, Eating1Product Code
- ILDAdaptor, Dressing1Product Code
- ILJBath, Hydro-Massage2Product Code
- ILKTransport, Patient, Powered2Product Code
- ILMBath, Sitz, Powered2Product Code
- ILOPack, Hot Or Cold, Water Circulating2Product Code
- ILSAdaptor, Hygiene1Product Code
- ILTAdaptor, Recreational1Product Code
- ILWAdaptor, Grooming1Product Code
- ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat2Product Code
- ILYLamp, Infrared, Therapeutic Heating2Product Code
- ILZAccessories, Traction1Product Code
- IMAPack, Heat, Moist1Product Code
- IMBCabinet, Moist Steam2Product Code
- IMCBath, Paraffin2Product Code
- IMDPack, Hot Or Cold, Disposable1Product Code
- IMEPack, Hot Or Cold, Reusable1Product Code
- IMFUnit, Chilling1Product Code
- INXBed, Air Fluidized2Product Code
- INYBed, Patient Rotation, Manual1Product Code
- IOADiathermy, Microwave, For Use In Applying Therapeutic Deep Heat2Product Code
- IOBLamp, Infrared, Non Heating2Product Code
- IODComponents, Exercise1Product Code
- IOEBars, Parallel, Exercise1Product Code
- IOGTreadmill, Mechanical1Product Code
- IOLTreadmill, Powered1Product Code
- IONExerciser, Non-Measuring1Product Code
- IOQBed, Flotation Therapy, Powered2Product Code
- IPFStimulator, Muscle, Powered2Product Code
- IRNDevice, Warning, Overload, External Limb, Powered2Product Code
- IROVibrator, Therapeutic1Product Code
- IRPMassager, Powered Inflatable Tube2Product Code
- IRQUnit, Heating, Powered1Product Code
- IRRBars, Parallel, Powered1Product Code
- IRSHead Halter, Traction1Product Code
- IRTPad, Heating, Powered2Product Code
- ISAMassager, Therapeutic, Electric1Product Code
- ISDExerciser, Measuring2Product Code
- ITHEquipment, Traction, Powered2Product Code
- JFAExerciser, Finger, Powered1Product Code
- JFBTable, Physical Therapy, Multi Function2Product Code
- KNLBoard, Scooter, Prone1Product Code
- KNMDevice, Pressure Applying1Product Code
- KTBDevice, Iontophoresis, Specific Uses2Product Code
- KTCBath, Sitz, Nonpowered1Product Code
- LBGDevice, Fluidized Therapy, Dry Heat2Product Code
- LSBUnit, Fluidotherapy2Product Code
- LXFDiathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- LXJInteractive Rehabilitation Exercise Devices2Product Code
- LYGMassager, Therapeutic, Manual1Product Code
- MPOInfant Heel Warmer (Chemical Heat Pack)1Product Code
- NGXStimulator, Muscle, Powered, For Muscle Conditioning2Product Code
- NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy2Product Code
- NYYStimulator, Muscle, Powered, With Limited Output, For Rehabilitation2Product Code
- NYZStimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning2Product Code
- OMWAdhesive Backed Thermal Skin Patches1Product Code
- OSDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature2Product Code
- PCDPowered Stairway Chair Lift2Product Code
- PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat2Product Code
- PHWCold Pack And Vibrating Massager1Product Code
- PKSExerciser, Non-Measuring For Stroke Rehabilitation1Product Code
- PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain2Product Code
- QKCInteractive Rehabilitation Exercise Device, Prescription Use2Product Code
- QKDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use2Product Code
- QTCAdult Portable Bed Rails For Medical Purposes1Product Code
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Exerciser, Non-Measuring For Stroke Rehabilitation
- Page Type
- Product Code
- Definition
- Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion.
- Physical State
- The device may consist of two arm frames mechanically linked that allow the user to use the unaffected arm to move the affect/weak arm. The device may also consist of a single frame that is used by both upper extremities simultaneously with the unaffected upper extremity facilitating movement of the affected upper extremity.
- Technical Method
- These devices are not powered exercise devices in that they do not provide movement to the user¿s upper limbs. The movement of the user's upper limbs is entirely governed by the user.
- Target Area
- Upper extremities
- Regulation Medical Specialty
- Physical Medicine
- Review Panel
- Physical Medicine
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 890.5370
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 890.5370 Nonmeasuring exercise equipment
§ 890.5370 Nonmeasuring exercise equipment.
(a) Identification. Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38818, July 25, 2001]