Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- PDQNeurosurgical Nerve Locator2Product Code
- HRWDynamometer, Nonpowered1Product Code
- KQWGoniometer, Nonpowered1Product Code
- KQXGoniometer, Ac-Powered1Product Code
- K011827ORTELIUS 8001Cleared 510(K)
- K971079INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE1Cleared 510(K)
- K9623773D-SPINE1Cleared 510(K)
- K961212SPINAL TOUCH1Cleared 510(K)
- K954647INCLINOMETER1Cleared 510(K)
- K943929DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)1Cleared 510(K)
- K945630LARGE MUSCLE STRENGTH GAUGE1Cleared 510(K)
- K943898SAUNDERS ELECTRONIC INCLINOMETER1Cleared 510(K)
- K940812INSIGHT ELECTRONIC ALIGNMENT INDICATOR1Cleared 510(K)
- K925225THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK1Cleared 510(K)
- K933063ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA1Cleared 510(K)
- K924416BOOST, MICE, GAMESYS.1Cleared 510(K)
- K922550ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)1Cleared 510(K)
- K920256SPINE MOTION ANALYZER WITH EMG1Cleared 510(K)
- K920690NOROTRACK 360 INCLINOMETER1Cleared 510(K)
- K914060RANGE OF MOTION SENSOR, MODEL RM0011Cleared 510(K)
- K914062NK DEXTERITLY BOARD, MODEL BX0011Cleared 510(K)
- K914061NK RANGE OF MOTION SENSOR, MODEL RM0021Cleared 510(K)
- K91307902810-01/02810-02 ORTHORANGER II/02810-3 ROM 3601Cleared 510(K)
- K897178DYNATRON 360 RANGE OF MOTION TESTING DEVICE1Cleared 510(K)
- K894283COMPREHENSIVE SPINE MOTION ANALYZER1Cleared 510(K)
- K893903KRONAMAX KUBE1Cleared 510(K)
- K893455THE HANDSCAN SYSTEM1Cleared 510(K)
- K884723(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM1Cleared 510(K)
- K884611THE ORTHORANGER II ELECTRONIC GONIOMETER1Cleared 510(K)
- K884003GONIOMETER AND BIOMEDICAL RECORDER SYSTEM1Cleared 510(K)
- K873599EDI 3201Cleared 510(K)
- K862128DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER)1Cleared 510(K)
- K852390CMT 10001Cleared 510(K)
- K832991HYPAL ADHESIVE TAPE1Cleared 510(K)
- K831040LAMOREUX-OSI ELECTROGONIOMETER1Cleared 510(K)
- K812908ELECTRO-GONIOMETER1Cleared 510(K)
- K810640POLARISED LIGHT GRONIOMETER1Cleared 510(K)
- LBBDynamometer, Ac-Powered2Product Code
- NKIGoniometer With Electrodes2Product Code
- QWPOptical Neurosurgical Nerve Locator2Product Code
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K933063
- 510(k) Type
- Traditional
- Applicant
- ISOTECHNOLOGIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/27/1994
- Days to Decision
- 219 days
- Submission Type
- Statement