(72 days)
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Not Found
No
The device description details a physical restraint system with mechanical components and no mention of software, data processing, or AI/ML terms.
No.
The device is described as a protective limb restraint used to limit patient movement for treatment, examination, or protection, rather than for directly treating a medical condition or ailment.
No
The device description clearly states its intended use is for protection and limiting patient movement, not for diagnosing any condition.
No
The device description clearly outlines physical components like neoprene, nylon cuff, Velcro® fastener, Quick-Release closure, Double D-Rings, and straps, indicating it is a hardware device.
Based on the provided information, the Heelbo ER Wrist Restraint is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "protective limb restraint that limits the patient's movement." This is a physical restraint used on the patient's body.
- Device Description: The description details a physical device made of neoprene, nylon, Velcro, and straps. It describes how it is applied to the wrist and secured to a bed or gurney.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body, which is the defining characteristic of an IVD. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the Heelbo ER Wrist Restraint is a medical device, but it falls under the category of a physical restraint, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Wrist
Indicated Patient Age Range
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Intended User / Care Setting
Caregiver
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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Image /page/0/Picture/1 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is black and appears to be the name of a company. The word "Heelbo" is followed by a comma, and then "Inc." indicating that it is an incorporated entity.
1134 N. Homan Ave. Chicago, IL 60651
312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
NOV -7 1996
Heelbo, Inc. Heelbo ER Wrist Restraint
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651
Contact Person Joseph S. Tokarz; Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 Ph: (847)680-2849, Fax: (847)918-3860
Date Summary Prepared - August 23, 1996
- Name of Device:
Heelbo ER Wrist Restraint
3. Name of Predicate Device
Heelbo ER Wrist Restraint
4. Description of 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 ER Wrist restraint can be used in the supine and 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 untving of knots. The Heelbo ER Wrist Restraint are machine washable.
5. Statement of Intended Use
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.
1
Heelbo, Inc.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo. Inc. Heelbo ER Wrist Restraint
6. Statement of Technological Characteristics of the Device
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 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 only difference is that the product labeling has been revised to comply with the Agency's labeling requirements set forth in the draft "Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints" dated December 1995.
7. Biocompatibility Assessment
The subject devices are identical in component materials to the predicate devices. Heelbo. Inc., is not aware of any reports or complaints of skin irritation associated with the materials used in these devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Heelbo ER Wrist Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device.
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