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510(k) Data Aggregation
K Number
K992733Device Name
AKRON ATP9 TRACTION MACHINE
Manufacturer
HUNTLEIGH TECHNOLOGY, INC.
Date Cleared
1999-11-10
(89 days)
Product Code
ITH
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
HUNTLEIGH TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical muscles and vertebrae when used in conjunction with fixed or variable height traction tables. It is indicated for use as a treatment for spinal root impingement, joint hypomobility, degenerative joint disease, discogenic pain and compression fractures.
Device Description
The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical muscles and vertebrae when used in conjunction with fixed or variable height traction tables. It is indicated for use as a treatment for spinal root impingement, joint hypomobility, degenerative joint disease, discogenic pain and compression fractures.
The ATP9 machine mounts on available Akron traction tables and mobile traction stand. Traction force is applied to the patient using Akron traction harnesses. The ATP9 utilizes a DC-powered motor gearbox connected to a rope drum via a clutch. The rope is connected to a harness attached to the patient. The high force hold time and low force rest time programs are selectable from 1 second minimum to 99 seconds maximum, with a high traction force range of 2-200 lbs. and low traction force range of 2-196 lbs. There are seven combinations of therapy including static, intermittent, progressive, regressive and cyclic.
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K Number
K964699Device Name
RHEO DOPPLEX II (RD 2)
Manufacturer
HUNTLEIGH TECHNOLOGY, INC.
Date Cleared
1997-02-21
(88 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HUNTLEIGH TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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