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510(k) Data Aggregation
K Number
K093553Device Name
POSTURETEK
Manufacturer
Date Cleared
2010-08-13
(269 days)
Regulation Number
N/AWhy did this record match?
Product Code :
LZW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PostureTek Shirt provides training to help the wearer use his own muscles to maintain the desired posture, thereby correcting poor posture and improving appearance.
Device Description
The POSTURETEK spinal curvature monitor is designed to be worn as a shirt, bra, tank top, or the like. Threaded in the garment is a monofilament, the tension of which changes depending upon the wearer's posture. If the wearer's posture is poor, an electronic disc located in the armpit region of the garment gently vibrates, alerting the wearer to correct his or her posture. The POSTURETEK device is easy to use, discrete, and durable.
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K Number
K081540Device Name
ZEGRA POSTURE TRAINER
Manufacturer
Date Cleared
2009-02-20
(263 days)
Regulation Number
N/AWhy did this record match?
Product Code :
LZW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the ZEGRA Posture Trainer is a postural reminder for people who have the habit of slumped posture, who wish to be reminded of their posture whenever they slump beyond a predetermined limit, and who have the ability to correct their posture, The ZEGRA Posture Trainer's feedback helps to reduce slumped posture within this population.
The intended use is for Prescription Use and Over-The-Counter Use.
Device Description
The ZEGRA Posture Trainer is worn and looks just like the predicate posture trainer by the name of SPINE TUNER (510k Number: K951244). It is strapped around the chest with a belt or a bra. All electronic components sit in a little plastic case. The case contains a part that is moved when the user slumps. This movement is picked up by a sensor within the case. When the ZEGRA Posture Trainer is switched on, a microprocessor records the current posture as posture threshold. Thereafter, the ZEGRA Posture Trainer will vibrate whenever this threshold posture is reached or surpassed by slumping too much. The user has a choice of immediate feedback or feedback with a few seconds delay. The ZEGRA Posture Trainer has no cables and no options for connecting with other devices. It is exclusively battery powered.
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