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- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- IKDCable, Electrode2Product Code
- IKETransducer, Miniature Pressure1Product Code
- IKKSystem, Isokinetic Testing And Evaluation2Product Code
- IKOHammer, Reflex, Powered2Product Code
- IKPChronaximeter2Product Code
- ISBStimulator, Muscle, Diagnostic2Product Code
- JFCSystem, Pressure Measurement, Intermittent1Product Code
- KHXPlatform, Force-Measuring1Product Code
- K951771COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM1Cleared 510(K)
- K946229BALANCE MANAGER1Cleared 510(K)
- K942694STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-3021Cleared 510(K)
- K930089SMS BALANCE PERFORMANCE MONITOR1Cleared 510(K)
- K921340FORCE MEASURING PLATFORM1Cleared 510(K)
- K901069COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM1Cleared 510(K)
- K893254DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER1Cleared 510(K)
- K883198BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM1Cleared 510(K)
- K883130BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 20001Cleared 510(K)
- K883129BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 20001Cleared 510(K)
Show All 15 Submissions
- OALExercise Equipment, Powered, Emg-Triggered2Product Code
- 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
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STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K942694
- 510(k) Type
- Traditional
- Applicant
- BIODEX MEDICAL SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/10/1995
- Days to Decision
- 276 days
- Submission Type
- Summary