Search Results

The Heelbo Waist and Chest Vest is intended to 1) help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair and 2) help prevent a patient from falling out of bed or climbing over slide rails.

The Heelbo Waist and Chest Vest is a poncho style safety vest that has two sets of two straps that are secured to a wheelchair to support the upper torso. When all the straps are connected per the instructions the Heelbo Waist and Chest Vest is intended to help prevent the patient from slumping or sliding forward while seated in a wheelchair and helps to prevent a patient from falling out of bed. The Waist and Chest Vest is available in a polyester/cotton blend (9340) or a polyester mesh material (9340B).

The provided text is a 510(k) summary for the Heelbo Waist and Chest Vest. It describes the device, its intended use, and compares it to predicate devices. However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the manner requested.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) based on intended use and technological characteristics, which is the primary requirement for a 510(k) premarket notification. This type of submission typically does not include extensive clinical trial data with specific performance metrics and acceptance criteria in the way a new, non-substantially equivalent device might.

Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from the provided text.

Here's what can be gathered:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics. The underlying "acceptance criteria" for a 510(k) submission are generally that the device is safe and effective for its intended use and is substantially equivalent to predicate devices.
• Reported Device Performance: The document claims the device is "safe and effective for its intended use and is substantially equivalent to the predicate device." However, no specific performance data (e.g., how effectively it prevents falls, or slumping) is provided.

Table (based on substantial equivalence comparison, not performance metrics):

2. help prevent a patient from falling out of bed or climbing over slide rails. |
   | Materials | Generally safe materials for patient contact (as evidenced by predicate) | Polyester Cotton Blend, Polyester Mesh (materials identical to previously cleared Heelbo devices K963099 and K963041) |
   | Number of straps | Same as predicate (2 straps) | 2 |
   | Where used | Same as predicate (wheelchair, geriatric chair, bed) | wheelchair, geriatric chair, bed |

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The submission relies on a comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is discussed.

4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes a medical device for physical support, not an AI-assisted diagnostic or imaging device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or software device.

7. The type of ground truth used: Not applicable in the context of a performance study. The "ground truth" for this 510(k) submission is the regulatory acceptance of the predicate devices as safe and effective.

8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an algorithm development.

9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.

Summary of available information regarding the "study":

The "study" in this context is the 510(k) submission itself, which primarily demonstrates substantial equivalence to predicate devices. The arguments presented are:

• Comparison Chart: A direct comparison of the proposed device's characteristics (intended use, materials, number of straps, where used) to a predicate device (Posey® Waist and Chest Vest) and other cleared Heelbo devices.
• Biocompatibility: The materials used are identical to those cleared in previous Heelbo devices (K963099, K963041). The suppliers have a history of safe use in clothing/garment, and Heelbo Inc. reports no adverse biological incidents over 15 years with these materials.

In essence, the document implies that because the device is technologically similar and has the same intended use as already legally marketed devices, it can be considered safe and effective without requiring new clinical performance studies.

Ask a specific question about this device

The Heelbo ER Wrist Restraint is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or elevated positions.

The Heelbo ER Wrist Restraint combines a neoprene and nylon cuff limb holder with a Velcro® fastener, Quick-Release closure, Double D-Rings, and two straps. The patient's wrist is secured into the neoprene and nylon cuff by Velcro® hook and loop straps and a Quick release closure. The attached webbed straps are then wrapped around the bed or gurney frame and are woven through a Double D-ring closure. This d-ring closure allows the caregiver to quickly and easily disconnect the restraint from the bed or gurney frame by eliminating time consuming untying of knots. The Heelbo ER Wrist Restraint are machine washable.

The provided text describes a medical device, the "Heelbo ER Wrist Restraint," but it does not contain information about acceptance criteria, a study proving device performance, sample sizes, expert involvement, adjudication methods, or complex statistical analyses like MRMC studies or standalone algorithm performance.

The document is a "Safety and Effectiveness Summary" which focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and evidence of meeting them.

Essentially, the document states:

• The device's description and intended use.
• Its technological characteristics.
• That it's identical in design, materials, manufacturing, physical/mechanical specifications, and safety/effectiveness to its predicate device.
• The only difference is updated product labeling to comply with regulatory guidance.
• A biocompatibility assessment indicating low potential for adverse reactions, based on existing materials and lack of prior complaints.
• A conclusion of safety, effectiveness, and substantial equivalence to the predicate device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document asserts equivalence rather than demonstrating performance against specific criteria.
2. Sample sized used for the test set and the data provenance: Not applicable, as no performance study is detailed.
3. Number of experts used to establish the ground truth... and the qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable.
6. If a standalone (i.e. algorithm only...) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Heelbo Security Belt is intended to help secure the patient while seated in a wheelchair or geriatric chair.

The Heelbo Security Belt is a padded belt 4% inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated.

This document is a 510(k) summary for a medical device (Heelbo Security Belt). It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic or AI-driven performance.

The information provided relates to the physical characteristics, materials, and intended use of a restraint belt, and its equivalence to an older version of the same product, primarily focusing on labeling changes.

Therefore, I cannot provide the requested information. The document does not describe:

• Acceptance criteria for a performance study (e.g., sensitivity, specificity, accuracy thresholds).
• Reported device performance statistics against such criteria.
• Sample sizes for test sets in a "study" of performance as typically understood for AI or diagnostic devices.
• Data provenance for such studies.
• Number/qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone algorithm performance study.
• Type of ground truth (e.g., pathology, outcomes).
• Sample size for the training set.
• How ground truth for the training set was established.

The "study" referenced in Section 8 is a conclusion based on substantial equivalence to a predicate device, primarily due to identical physical characteristics and materials, with the only change being a revision to product labeling to comply with FDA guidance. This is a regulatory pathway, not a performance study as would be conducted for a new diagnostic or AI-based device.

Ask a specific question about this device

The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails.

The Heelbo Pullover Poncho and Pullover Poncho with Pocket are poncho-style safety vests. The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails. The Heelbo Pullover Poncho has two straps that secure to the bed frame, wheelchair or geri-chair frame while the Pullover Poncho with Pocket has four straps that secure the bed frame, wheelchair or geri-chair frame. The Pullover Poncho with pocket provides the patient with a pocket to put personal items in. Both Heelbo Poncho restraints are available in a poly/cotton blend or a polyester mesh material and are available in five sizes to accommodate a wide range of patients. Both styles of pullover poncho are machine washable for continued use.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The text describes the device, its intended use, and states that it is substantially equivalent to predicate devices, but lacks the details requested in your prompt.

Ask a specific question about this device

The Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.

The Heelbo Life Jacket with Crotch Support is a poncho-style safety vest with padded crotch support. The vest has three sets of two straps that are secured to various components of a wheelchair or geriatric chair to support the upper torso. When all the straps are connected per the instructions the Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.

The Life Jacket with Crotch Support is available in a polyester and cotton blend (9400) or a polyester mesh material (9400B).

The provided text is a 510(k) summary for the Heelbo Life Jacket with Crotch Support. It is a regulatory document intended to demonstrate substantial equivalence to a predicate device, not a study describing the de novo establishment of acceptance criteria and device performance. As such, the document does not contain the information requested regarding acceptance criteria from a study for a new device.

Specifically, the document focuses on demonstrating that the "new" Heelbo Life Jacket with Crotch Support is identical to its predicate device, with the only change being a revision to product labeling to comply with regulatory guidance. It explicitly states:

• "The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification."
• "The subject devices are identical in components materials to the predicate devices."

Therefore, it does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Multi-reader multi-case comparative effectiveness studies.
6. Standalone algorithm performance (as this is a physical device, not an algorithm).
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document serves as evidence of substantial equivalence based on a change in labeling for an existing device, rather than a clinical study evaluating the performance of a newly designed device against specific acceptance criteria.

Ask a specific question about this device

Heelbo Quilted Limb Holder with Buckle and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.

The Heelbo Quilted Limb Holder with Buckle and Strap is a quilted limb holder with a Velcro® fastener, buckle and straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Buckle and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The adjustable buckle allows for supine and sitting positions. The Heelbo Quilted Limb Holder is machine washable.

This document is a 510(k) premarket notification for a medical device called the "Heelbo Quilted Limb Holder with Buckle and Strap." It makes claims of substantial equivalence to a predicate device, rather than providing new clinical study data or performance metrics that would typically be associated with software or AI device acceptance criteria.

Therefore, many of the requested sections (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to the information provided in this submission.

Here's an analysis based on the available text:

1. A table of acceptance criteria and the reported device performance

Study that proves the device meets the acceptance criteria:

The submission itself serves as the "study" or justification. It makes a claim of substantial equivalence to a previously cleared predicate device, the "Heelbo Quilted Limb Holder with Buckle and Strap." The "proof" is the assertion that the new device is identical in all critical aspects (intended use, design, materials, manufacturing process, physical and mechanical specifications, safety, and effectiveness) to the predicate, with the only change being updated labeling for regulatory compliance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission based on substantial equivalence to a predicate device, not on new clinical trials or performance data generated from a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No new ground truth was established for a test set for this submission. The safety and effectiveness are predicated on the established history of the legally marketed predicate device and its materials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical limb holder, not an AI or software-based device intended for diagnostic interpretation or human reader assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" implicitly relies on the historical safety and effectiveness established for the predicate device through its prior clearance and market experience. For biocompatibility, the ground truth is the "history of safe use of their materials in the clothing and garment industry" and the absence of reported skin irritation complaints.

8. The sample size for the training set

Not applicable. No training set for an algorithm was used.

9. How the ground truth for the training set was established

Not applicable. No training set for an algorithm was used.

Ask a specific question about this device

Heelbo Ouilted Limb Holder with Double D-Ring. Ouick-Release Snap, and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.

Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is a disposable quilted limb holder with a Velcro® fastener, Double D-Ring, Quick-Release Snap and Straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The Heelbo Quilted Limb Holder allows for wrist adjustment to provide a secure fit without cinching. The Double D-Ring is simple to use and allows the caregiver easy access to the patient. Also, the adjustable Double D-Ring and Quick-Release Snap allow for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable.

The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is available in the following sizes:

Stock No. 9350 Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long

Stock No. 9360 Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification summary for a medical device (Heelbo Quilted Limb Holder), focusing on its intended use, description, and substantial equivalence to a predicate device. It addresses aspects like technological characteristics and biocompatibility based on material history of safe use, but it does not detail specific performance metrics, clinical studies, or expert evaluations as requested in the prompt.

Therefore, I cannot extract the information needed to fill out the table and answer the questions about acceptance criteria and a detailed study.

Ask a specific question about this device

The Inch Quilted Limb Holder with quick release closure is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions

The Inch Quilted Limb Holder with quick release snap closure is a quilted limb holder with a Velcro® fastener, quick release snap closure and straps that secure to a bed, gurney, chair, geri-chair or wheelchair. The Inch Quilted Limb Holder with quick release closure is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The Inch allows for wrist adjustment to provide a secure fit without cinching. The knotless quick release snap closure is simple to use and allows the caregiver fast and easy access to the patient. A slide harness allows for supine or sitting positions. The Inch limb holders are machine washable.

This document describes a medical device called "The Inch Quilted Limb Holder" and its safety and effectiveness summary for a 510(k) submission. However, the provided text does not contain any information regarding acceptance criteria, study details, sample sizes for test or training sets, ground truth establishment, expert involvement, or any performance metrics expected for such a study.

The document primarily focuses on:

• Administrative details: Submitter information, device name, predicate device.
• Device description: Physical characteristics, intended use, variations.
• Technological characteristics statement: Explicitly states the subject devices are identical to predicate devices in all aspects (intended use, design, materials, manufacturing, specs, safety, effectiveness). The only difference cited is revised product labeling to comply with Agency requirements.
• Biocompatibility assessment: Also states the devices are identical in component materials to predicate devices, and that suppliers have a history of safe use in the clothing industry, with no reported skin irritation complaints.
• Conclusion: Based on the above, the device is considered safe, effective, and substantially equivalent to the predicate device.

Therefore, it is impossible to answer the user's questions as the requested information (acceptance criteria, study details, performance data) is not present in the provided text.

The document is a premarket notification for a device that is claimed to be substantially equivalent to an existing one, with the primary change being labeling. In such cases, extensive new performance studies proving acceptance criteria are often not required, as the safety and effectiveness are established by the predicate device.

Ask a specific question about this device

Heelbo Quilted Limb Holder with Double D-Ring and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.

Heelbo Quilted Limb Holder with Double D-Ring and Strap is a quilted limb holder with a Velcro® fastener, Double D-Ring and Straps that secure to a bed, gurney, chair, gerichair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The adjustable Double D-Ring allows for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable.

The Heelbo Quilted Limb Holder with Double D-Ring and Strap is available in the following sizes: Stock No. 9320 Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long Stock No. 9330 Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long

The provided document describes a medical device, the "Heelbo Quilted Limb Holder with Double D-Ring and Strap," and its safety and effectiveness summary for a 510(k) submission. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic or AI-powered device would.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is a common pathway for medical device clearance in the US, rather than demonstrating performance against a predefined set of acceptance criteria through a specific study.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to performance studies and evaluations typically conducted for devices with measurable outputs or diagnostic capabilities.

Here's an explanation based on the available information:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.). The "acceptance criterion" for this submission is implicitly related to demonstrating substantial equivalence to a predicate device.
   • Reported Device Performance: Not reported in quantitative terms like those expected for a diagnostic or AI device. The document states that the device is "safe and effective for its intended use and is substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable/not provided. No test set involving patient data or device performance evaluation on a "test set" as typically understood for AI or diagnostic devices was described.
   • Data Provenance: Not applicable/not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/not provided. No ground truth establishment Process is described.

4. Adjudication method for the test set:

   • Not applicable/not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was described. This device is a physical restraint, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

   • Not applicable. There is no mention of ground truth as typically understood for diagnostic device validation. The basis for "safety and effectiveness" appears to be the design, materials, manufacturing process, physical and mechanical specifications, and intended use being identical to a predicate device, coupled with a history of safe use of materials in the clothing industry and absence of skin irritation reports.

8. The sample size for the training set:

   • Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

   • Not applicable.

In summary, this document is a 510(k) premarket notification for a physical medical device, the Heelbo Quilted Limb Holder. Its purpose is to demonstrate substantial equivalence to an already legally marketed predicate device rather than to present performance data from a clinical trial or algorithmic validation study against specific acceptance criteria. Therefore, the detailed information requested about performance studies is not present in this type of submission.

Ask a specific question about this device

The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient's movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails.

The Heelbo Wrap Around Vest is a crisscross-style safety vest. The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient's movement while lying on a bed or gurney to prevent the patient from falling out of bed or climbing over the side rails.

The vest is secured to the bed or wheelchair frame with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed.

The Wrap Around Vest is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots.

The Wrap Around Vest is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Wrap Around Vest is made of durable machine washable materials and is color coded for easy size identification.

The provided document is a 510(k) Premarket Notification for a medical device called the "Heelbo Wrap Around Vest." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel safety and effectiveness through clinical studies with acceptance criteria in the typical sense of AI/algorithm performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI algorithm, specifically:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set details.
• The type of ground truth used for any such studies.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device by comparing:

• Intended use
• Technological characteristics (design, materials, manufacturing, physical/mechanical specifications)
• Safety and effectiveness

Here's a summary of what the document does state regarding safety and effectiveness:

• Intended Use: The device is intended to help support and prevent patients from slumping/sliding forward in a wheelchair or geriatric chair, and to limit patient movement in bed/gurney to prevent falls or climbing over side rails.
• Technological Characteristics Comparison: The document explicitly states: "The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification."
• Biocompatibility: The materials are identical to predicate devices, and suppliers have a history of safe use in the clothing and garment industry. Heelbo, Inc. is unaware of reports or complaints of skin irritation.
• Conclusion: Based on the information, the proposed Heelbo Wrap Around Vest is concluded to be "safe and effective for its intended use and is substantially equivalent to the predicate device."

In essence, the "study" demonstrating safety and effectiveness in this context is a detailed comparison to an already cleared predicate device, rather than a clinical trial with statistical performance metrics.

Ask a specific question about this device