(88 days)
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.
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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 is set against a white background. A thin black line underlines the text, adding a subtle visual element to the composition.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
OCT 18 1996
Heelbo, Inc. The Inch Quilted Limb Holder
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL
Contact Person Joseph S. Tokarz, Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847)680-2849, Fax: (847)918-3860 Ph:
Date Summary Prepared - July 17, 1996
2. Name of Device:
The Inch Quilted Limb Holder with quick release snap closure
3. Name of Predicate Device(s)
The Inch Quilted Limb Holder with quick release snap closure
4. Description of Device
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.
The Inch Quilted Limb Holders are available in the following sizes, variations and types of assembly to accommodate the various needs of the user. (See chart on next page)
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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. The Inch Quilted Limb Holder
| The Inch Quilted Limb Holder Availability | |||
|---|---|---|---|
| Unit | Series | Cuff Size(inches) | Description |
| Pack | |||
| 6 pr | 7700 | Small/Reg up to 11½" long | unassembled quick release snap closure |
| 6 pr | 7710 | Large/XL up to 12½" long | strap and one tie down strap |
| 6 pr | 7715 | Small/Reg up to 11½" long | pre-threaded quick release snap closure |
| 6 pr | 7718 | Large/XL up to 12½" long | strap and one tie down strap |
| 6 pr | 7700-DS | Small/Reg up to 11½" long | unassembled quick release snap closure |
| 6 pr | 7710-DS | Large/XL up to 12½" long | strap and two tie down straps |
| 6 pr | 7720 | Small/Reg up to 11½" long | pre-threaded quick release snap closure |
| 6 pr | 7725 | Large/XL up to 12½" long | strap and one quick release loop accessory |
| 6 pr | 7735 | Youth up to 9" long | (quick release loop accessory isreplacement part*, series 7775) |
| 6 pr | 7730 | toddler up to 9" long | toddler quilted limb holder with Velcro®and two tie down straps |
| 10 ea | 7775 | replacement part | quick release loop accessory** |
・】 〇 ・ 1 ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・
- a quick release loop accessory that is secured to a chair/bed allows for fast release and eliminates the step of untying knots or cutting straps.
- ** Series 7775 is included with Series 7720, 7725 and 7735. It is also sold separately as a replacement part for Series 7720, 7725 and 7735.
5. Statement of Intended Use
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
6. Statement of Technological Characteristics of the Device
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.
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Image /page/2/Picture/0 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 or organization. The word "Heelbo" is followed by a comma and then "Inc.", which is likely an abbreviation for "Incorporated."
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. The Inch Ouilted Limb Holder
6. Statement of Technological Characteristics of the Device (con't)
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 [501(k)] Submissions for Protective Restraints" dated December 1995.
7. Biocompatibility Assessment
The subject devices are identical in component materials to the predicate devices. The suppliers of the materials use in the fabrication of these devices have stated that there is a history of safe use of their materials in the clothing and garment industry. In addition, Heelbo, Inc., is not aware of any reports or complaints of skin irritation associated with these materials.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Inch Quilted Limb Holders are safe and effective for their intended use and are substantially equivalent to the predicate device.
§ 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.