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510(k) Data Aggregation
K Number
K172536Device Name
Atlas Percussion Adjusting Instrument
Manufacturer
Spinalight, Inc
Date Cleared
2018-06-20
(302 days)
Product Code
LXM
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Spinalight, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spinalight Atlas Percussion Instrument is to be used by a licensed Chiropractor to assist in making a Chiropractic adjustment to the atlas vertebrae. This adjustment is indicated when the doctor believes this bone to be out of alignment.
Device Description
The Percussion Adjusting Instrument is comprised of a Chiropractic Adjusting Table and a support system with a percussion device, which a Chiropractor positions over his patient to deliver an adjustment to the Atlas Vertebra (C-1). After the doctor positions the patient on the table, he aligns the instrument head so that the stationary stylus is positioned to the Atlas on predetermined vectors. Once this is completed the Chiropractor activates a solenoid contained within the adjusting head which strikes the proximal end of the stationary stylus generating a percussion wave through the stylus into the transverse process of the Atlas Vertebra. The objective is to produce a movement of the Atlas toward its proper alignment under the skull. Any time the patient is being positioned on the table or headpiece the percussion head is placed in the "Safe to Move" position.
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K Number
K001476Device Name
TORQUE INSTRUMENT, MODEL 8500
Manufacturer
SPINALIGHT, INC.
Date Cleared
2000-08-04
(85 days)
Product Code
LXM
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SPINALIGHT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955540Device Name
HAND HELD ATLAS INSTRUMENT
Manufacturer
SPINALIGHT, INC.
Date Cleared
1996-03-04
(90 days)
Product Code
LXM
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SPINALIGHT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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