(80 days)
Not Found
Not Found
No
The device description and intended use clearly describe physical restraints made of materials like silicone rubber, nylon webbing, and vinyl. There is no mention of any software, data processing, or intelligent capabilities.
No
The device is described as a restraint system "intended to limit movement of severely agitated persons who may cause harm to themselves or to others." This indicates its primary purpose is physical containment for safety, not therapeutic treatment or rehabilitation.
No
The device description and intended use clearly state that these devices are physical restraints used to limit movement and prevent harm, not to diagnose medical conditions.
No
The device description details multiple physical components made of materials like silicone rubber, mylar, steel, nylon webbing, and vinyl, all of which are hardware. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "limit movement of severely agitated persons who may cause harm to themselves or to others if not restrained." This is a physical restraint device used on a living person.
- Device Description: The descriptions detail physical restraints made of materials like silicone rubber, nylon webbing, and vinyl, with various closures and attachments for securing limbs and the torso.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing specimens (blood, urine, tissue, etc.)
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Use in vitro (outside of a living organism).
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical restraint used directly on a person.
N/A
Intended Use / Indications for Use
Other than the fleece liner, all devices are intended to limit movement of severely agitated persons who may cause harm to themselves or to others if not restrained. The fleece liner is an accessory to reduce chatling when used with the silicone rubber cuff. Where locks are a part of the device, they are for the purpose of lessening the chance of unauthorized re-lease.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
- Silicone Rubber Cuff: The device is made of silicone rubber molded over a 0.015 inch mylar insert. A nickel plated oblong shaped steel loop is riveted on one end that can be inserted into one of 5 slots on the other end as the first step in securing
- Nylon Bed Restraints (Wrist): The device is attached to the bed frame using a 2" x 12 foot nylon webbing strap with either two sewn on L-400 lock or two sewn-on 2" polyethylene side-release buckle with 2" slide bar, each attached 38" from each end. Two 2" x 12" (wrist) or two 2" x 14" (ankle) fleece-lined culls are sewn on to the 64" length of nylon webbing each either 14" (wrist) or 9" (ankle) from the center. The culls are available with a choice of 4 different types of closures: a 1" polyethylene side release buckle with 1" polyethylene slide bar, an L-400 lock, a 1 1/2" double D ring buckle, or a polypropylene web buckle.
- Nylon Torso Restraint: A 2" x 96" nylon webbing torso restraint is available in one size. The restraint is place over the chest or upper legs and secured to a bed with cither two L-400 lock buckles or two 2" polyethylene side-release buckle, each sewn 28" from the end. The restraint is optional for use with wrist restraints to prevent the restrained person from sitting up in the bed.
- Nylon Transporter: This device consists of a 2" x 64" nylon webbing waist belt with two 2" x 12" nylon webbing wrist culls sewn on, the first 9" from the keeper, the second, 13" from the first. The waist belt is secured in back with a 2" polyethylene side release lock with 2" slider bar, the wrist cuffs are double secured with 4 1/4 inches of 1-1/2" hook and loop closure and twin D rings sewn onto the cuff along with a 1" x 18" black nylon webbing strap to cinch the D rings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist, Torso, Ankle, Chest, upper legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The devices are not intended for lay use. The health care facilities where our devices are used are subject to the Health Care Financing Administration (HCFA) rules and usually meet accreditation standards.
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.
Not Found
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
§ 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.
0
K9603485
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:
Image /page/0/Picture/1 description: The image shows the words "Humane Restraint" in a bold, sans-serif font. The words are stacked on top of each other, with "Humane" on the top line and "Restraint" on the bottom line. The text is black and the background is white. The dot on the i in Restraint is a circle.
NOV 22 1996
TAB F: 510(k) Summary of Safety and Effectiveness
Name, address, phone and fax numbers for person submitting the 510(k) notification:
Stacy Schultz, Product Manager Humane Restraint Company, Inc. 912 Waunakee, WI 53597 Phone: 1-800-356-7472 Fax: 1-608-849-6315
Contact Person: Stacy Schultz
Date summary was prepared: August 28, 1996
Device name:
Trade name(s):
- Silicone Rubber Cuff Fleece Liner Web Torso Restraint Nylon Limb Holder Vinyl Limb Holder Nylon Bed Restraint (wrist) Nylon Torso Restraint Nylon Transporter
Common name: Same Classification name: Protective Restraint
Predicate device:
The fleece liners, silicone rubber cuffs, web torso restraints, nylon limb holders, vinyl limb holders, nylon bed restraints (wrist), nylon torso restraint, and nylon transporter, all legally marketed at this time. The devices described in this submission are our currently marketed products. This submission is in response to 61 FR 8431 -8439, Protective Restraints; Revocation of Exemptions From the 510(k) Premarket Notification Procedures and Current Good Manufacturing Practice Regulations.
Device Description:
- Silicone Rubber Cuff: The device is made of silicone rubber molded over a 0.015 ટી. inch mylar insert. A nickel plated oblong shaped steel loop is riveted on one end that can be inserted into one of 5 slots on the other end as the first step in securing
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1
()แวนประจะ-ราช [le) รูปิอย โฆษาที่สุด พ.ศ. 17 น. 11:4 ระ วิธ เพลิศ ระ ราคารสารทรวงศ์ เ ind dispossible fleere Inner) ວາດສຸງ ເຊິ່ງເອກາງ ລວຍໄປ xi door ງວຽງຮູ້ ລາວ 100 ສິບາງຫວັດລາວ ווו ןגאל ובואלן ווא. oldeliver thating. Is assuredity is newsley - The collerent to readers and assimbly Restraint ( The City is may be covered with the official postposity the co separately and have pecil marketed for more than 100 years by the I humans and ון לוב לוכאוכב זי זו אינולו יותר זה אחדות והווקן במלוכן או או או או או או או או אייני או sos ક્ષિત મારા તાલુકામાં આવે છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ ભાગમાં આવેલા ગુજરાત રાજ્યના દિવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા
- し over the cull the with Frans of strings of chirds of chief the finer when shown ນຂອງໂບ້ດ 10 ວັນທານ ຄຳ ກິນວ ອໄປ້ ວິໄປຜູ້ເສຍຮ ຂວາວ ປີ ປັນນ ນ້ຳທາ ນາມ ການປະຊາວບາດວ່າ ຂອງປະເທ Ship Ship in is is in in aldelines bus ship since in two lengthy stirf ນສາຂອງ ວາທະລາວ ວຽງ 20 ປີນາ ລາວ ເວທີມາ ວາດ 10 ປີນາ ລາຍງາມການສາດສາດສາຫານ 100 ກອນ 2000 ກິ 1) 2isposable Fleece Liner (The lesther confights betwiss to be hamme Reserver from 100 years - This is and any guiped charing all and and a sure a
- C of shuistisse dum this as a rol fenonde and one portugue for me mind finning the may bad ui du guittis moth nostad в техно ร อานววร () ท่ายหมาย อาหารเมริการราชวิต อย่าง) อ้าง ประเทศ มีนาคม พระบรวม מונובחיניון 16" olds is a mirristes ocean particles - 00 = mulbert (vir - 10 = 11:10 = 10 = 11:10 + 11:11 + 11:10 + 11:11 + 11:11 + 11:11 + 11:11
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- C sure on other outside of the performed viny to the coff its the write lo questo i seven on the the old to sitt of the ciff. Two types of forms ນອາເຣນປາວປຸ ນ ນີ້ລະນີ ຈວລອຖື ເອາຣວ ຖິງນາ ວັນການປະທະ of the down no-mass to guidden monym of to the most sport of the left the state www.ighing for attachment to shouldaw of with mylon medding strate 1 this." studio musics of look and ath of relaxibless and of the oth tighouth salts gunders nation
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- 2 S --
2
- Nylon Bed Restraints (Wrist): The device is attached to the bed frame using a 2" x に 12 foot nylon webbing strap with either two sewn on L-400 lock or two sewn-on 2" polyethylene side-release buckle with 2" slide bar, each attached 38" from each end. Two 2" x 12" (wrist) or two 2" x 14" (ankle) fleece-lined culls are sewn on to the 64" length of nylon webbing each either 14" (wrist) or 9" (ankle) from the center. The culls are available with a choice of 4 different types of closures: a 1" polyethylene side release buckle with 1" polyethylene slide bar, an L-400 lock, a I ½" double D ring buckle, or a polypropylene web buckle.
- Nylon Torso Restraint: A 2" x 96" nylon webbing torso restraint is available in tic one size. The restraint is place over the chest or upper legs and secured to a bed with cither two L-400 lock buckles or two 2" polyethylene side-release buckle, each sewn 28" from the end. The restraint is optional for use with wrist restraints to prevent the restrained person from sitting up in the bed.
- Nylon Transporter: This device consists of a 2" x 64" nylon webbing waist belt ﺷ with two 2" x 12" nylon webbing wrist culls sewn on, the first 9" from the keeper, the second, 13" from the first. The waist belt is secured in back with a 2" polyethylene side release lock with 2" slider bar, the wrist cuffs are double secured with 4 1/4 inches of 1-1/2" hook and loop closure and twin D rings sewn onto the cuff along with a 1" x 18" black nylon webbing strap to cinch the D rings.
Intended Use:
Other than the fleece liner, all devices are intended to limit movement of severely agitated persons who may cause harm to themselves or to others if not restrained. The fleece liner is an accessory to reduce chatling when used with the silicone rubber cuff. Where locks are a part of the device, they are for the purpose of lessening the chance of unauthorized release.
The following chart describes the device applications. >
Humane Restraint Company Summary of Safety and Effectiveness Various Protective Restraints Page 3 of 6
3
dications for use (continu
| DEVICE | LOCKS | | APPLICATION
AMBULATORY | | | | BED | | | NOTES | CATALOG
PAGE # | DEVICE | YEARS |
|-----------------------------|-------|---------|---------------------------|-------------------|-----------------|-----------------|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----|-----------------------------|-------------------|----------------------|-------|
| | WITH | WITHOUT | WRIST
TO WRIST | ANKLE
TO ANKLE | WRIST
TO BED | ANKLE
TO BED | TORSO
TO BED | | | | | Silicone Rubber Cuff | 1 |
| Silicone
Rubber
Cuff* | N/A | N/A | X | X | X | X | | To be used with locking or
non-locking leather belts
(pre-1976) and torso and/or
chest restraints and/or
optional fleece liners ** | 2 | Disposable Fleece Liner | 1 | | |
| Web Torso
Restraint | X | X | | | | | X
(waist) | Optional use with limb
holders | 12 | Web Torso Restraint | 19 | | |
| Nylon Limb
Holder | X | X | | | | | | Optional use with chest or
torso restrains | 9 | Nylon Limb Holder | 1 | | |
| Vinyl Limb
Holder | X | X | | | X | X | | Optional to use with chest
or torso restraints | 9 | Vinyl Limb Holder | 4 | | |
| Nylon Bed
Restraints | X | X | | | X | X | | May be used with optional
nylon chest restrain | 9 | Nylon Bed Restraint (wrist) | 4 | | |
| Nylon Torso
Restrain | X | X | | | | | X
(chest and
upper leg) | Optional to use with nylon
bed restraint system | 9 | Nylon Torso Restraint: | 4 | | |
| Nylon
Transporter | | X | X | X | | | | | 15 | Nylon Transporter | 5 | | |
Humane Restraint Company
Summary of Safety and Effectiveness
Various Protective Restraints
Page 4 of 6
4
Comparative information:
The devices used for comparative purposes are exactly the same as devices currently marketed by the Humane Restraint Company and as described in this submission.
These devices are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by the Humane Restraint Company as of the date of this submission. The Humane Restraint Company has hecn manufacturing and commercially distributing these devices for the number of years as follows:
In addition to the devices listed and described in this submission, the Humane Restraint Company has been marketing devices with similar in designs but using different materials for more than 20 years. We have had no reports of injury for any of our products.
These restraint are intended and labeled for prescription use. The devices are not intended for lay use. The health care facilities where our devices are used are subject to the Health Care Financing Administration (HCFA) rules and usually meet accreditation standards. HCTA rules governing appropriate use of these devices and accreditation standards specifying conditions for device use and required personnel training provide controls necessary to ensure that the devices are used correctly. The application of these standards along with public awareness, and health care provider training have contributed significantly to ensuring that the least restraint is used, that restraints are used only when needed for proper medical treatment, and that their use is under appropriate supervision.
Use Restrictions for Restraints
The use of all patient restraints is subject to Health Care Financing Administration's Regulations which prohibit the use of any restraint, physical or chemical, imposed for the purpose of discipline or convenience and specify that the patient situation be evaluated to assure that the least restrictive restraint is used.
Himane Restraint Company Summary of Safety and Effectiveness Various Protective Restraints Page 5 of 6
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5
Accreditation Training Requirements
Further, the "Revised Standards for Restraint and Scclusion", TX.7.1.3.2.4, 1996 Accreditation Manual for Hospitals, Volume 1, Joint Commission on Accreditation of I Icalthcare Organizations apply to all organizations accredited under the 1996 AMH, Volume 1, the Comprehensive Accreditation Manual for Ambulatory Care, and the Accreditation Manual for Mental Health, Chemical Dependency, and Mental Retardation-Developmental Disabilities.
These standards require that restraint be used correctly by competent trained staff. Organizations must identify, educate and determine competency of those staff members who apply or remove restraints and that the training consist of frequently repeated inservice education, including an understanding of manufacturers instructions for use of restraint device.
Humane Restraint Company Summary of Safety and Effectiveness Various Protective Restraints Page 6 of 6
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