(263 days)
Not Found
No
The device description details a simple sensor and microprocessor that triggers a vibration based on a predetermined posture threshold, with no mention of learning, adaptation, or complex algorithms typically associated with AI/ML.
Yes
The device is intended to reduce slumped posture and helps users correct their posture, aligning with the definition of a therapeutic device designed to treat or alleviate a health condition.
No
The device is described as a "postural reminder" that vibrates when a user slumps too much, helping to reduce slumped posture. Its function is to provide feedback for posture correction, not to diagnose a medical condition.
No
The device description explicitly states it contains electronic components within a plastic case, including a sensor, microprocessor, and battery, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the ZEGRA Posture Trainer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ZEGRA Posture Trainer Function: The ZEGRA Posture Trainer is a wearable device that monitors the user's posture and provides feedback (vibration) when they slump. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is to remind users of their posture and help them reduce slumped posture. This is a physical and behavioral intervention, not a diagnostic test performed on a sample.
Therefore, the ZEGRA Posture Trainer falls under the category of a physical or behavioral aid, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LZW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Revised 510(k) Summary
FEB 20 2009
Type:
Traditional
Submitter:
Peter Fischer Christophstr. 2 D72072 Tuebingen Germany Tel: 01149-7071-368683 Fax: 01149-7071-368682 E-mail: ZEGRA@orthentics.com
Contact person:
Peter Fischer Tel: 01149-7071-255303 E-mail: ZEGRA@orthentics.com
Preparation date:
Trade name:
Common name:
Classification name:
Class:
Product code:
Panel:
Physical Medicine
January 23rd, 2009
Posture trainer
unclassified
LZW
ZEGRA Posture Trainer
Monitor, Spine Curvature
Substantial equivalence:
Device Classification Name - Monitor, Spine Curvature 510(k) Number - K951244 Device Name - SPINE TUNER POSTURE TRAINER Applicant - Dan Kline, 1816 West Cliff Ct, Carlsbad, CA 92008 Contact - Dan Kline Classification Product Code - LZW Date Received - 03/13/1995 Decision Date - 06/26/1995 Decision - Substantially Equivalent (SE) Classification Advisory Committee - Physical Medicine Review Advisory Committee - Physical Medicine Statements/Summary/Purged Status - Statement Only Type - Traditional
Reviewed By Third Party - No
The submitter was informed by FDA staff, that the predicate device "SPINE TUNER posture trainer" is an unclassified pre-amendments device. Thus he expects that the Classification Advisory Committee "Physical Medicine" will classify the substantially equal "ZEGRA posture trainer" in the same way.
1
K081540
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.
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.
Substantial equivalence:
Intended use:
A sensor and feedback unit encased in a plastic housing. The housing being attached to the body via a belt or bra. The sensor being sensitive to spinal curvature. A vibratory feedback signal whenever and as long as the spine is flexed beyond a predetermined limit.
Battery power as the only energy source.
A target population that wants to improve its posture and has the ability to do so.
Main difference to predicate:
Main difference to predicate: The ZEGRA posture trainer has a choice of immediate and delayed feedback, while the predicate device only offers immediate feedback.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple and iconic, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Peter Fischer % Christophstr. 2 Mr. Peter Fischer D72072 Tuebingen Germany
FEB 2 0 2009
Re: K081540 Trade Name: ZEGRA Posture Trainer Regulatory Class: Unclassified Product Code: LZW Dated: January 23, 2009 Received: February 3, 2009
Dear Mr. Fisher:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing may regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Peter Fischer
Enclosure
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)); please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
· Sincerely yours,
Mark N Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices . Office of Device Evaluation Center for Devices and Radiological Health
4
. 's
Indications for Use
.
510(k) Number (if known): K081540´¨
Device Name: ZEGRA Posture Trainer
Indications For 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.
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
|-------------------------------------------------|------------------------------------------------|------------------------------------------------|
| ☑ | | ☑ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| Page 1 of | 1 |
|---|---|
| ----------- | --- |
| 510(k) Number | L081540 |
|---|---|
| --------------- | --------- |