Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- 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
- QQOCranial Measurement Software1Product Code
- HSTApparatus, Traction, Non-Powered1Product Code
- K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table1Cleared 510(K)
- K110858LO-BAK TRAX1Cleared 510(K)
- K984190BACK-ON-TRAC, MODEL 101BOT1Cleared 510(K)
- K872121K AND D HOME TRACT1Cleared 510(K)
- K870212ARTHROSCOPIC SHOULDER HOLDER1Cleared 510(K)
- K870125EXTREMITY ELEVATOR1Cleared 510(K)
- K870102TUPPER TROLLEY1Cleared 510(K)
- K864765MODEL 668, TRACTION SPLINT, ADULT1Cleared 510(K)
- K862874THE TOWERED 90/90 UNIT1Cleared 510(K)
- K860037SUSPENDER ORTHOPEDIC SUSPENSION DEVICE1Cleared 510(K)
Show All 38 Submissions
- ONONeurosurgical Laser With Mr Thermography2Product Code
- 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
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- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
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- UnknownReview Panel
LO-BAK TRAX
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K110858
- 510(k) Type
- Traditional
- Applicant
- ROLAND F BERTHIAUME, DC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/2/2011
- Days to Decision
- 127 days
- Submission Type
- Summary