SAFETY VEST
K962429 · Johnson & Johnson Professionals, Inc. · FMQ · Sep 18, 1996 · General Hospital
Device Facts
| Record ID | K962429 |
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| Device Name | SAFETY VEST |
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| Applicant | Johnson & Johnson Professionals, Inc. |
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| Product Code | FMQ · General Hospital |
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| Decision Date | Sep 18, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 880.6760 |
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| Device Class | Class 1 |
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| Attributes | Therapeutic |
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Intended Use
The Johnson & Johnson Safety Vests are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them. These products can be used in restraining patients to a bed or chair. The Johnson & Johnson Limb Holders are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them. These products can be used in restraining patients to a bed or chair.
Device Story
Safety vests and limb holders; used to restrain patients to beds or chairs to prevent self-injury or medical care interruption. Vests: lightweight nylon mesh, webbed tie straps, shoulder loops. Limb holders: canvas wrist protector with cotton lining/polyester strap or nylon laminated foam with hook/loop closure and polyester straps. Operated by clinical staff in healthcare settings. Provides physical containment to ensure patient safety.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Materials: nylon mesh, cotton canvas, cotton lining, polyester straps, nylon laminated foam. Form factor: wearable restraints with tie straps or hook and loop closures. No electronic components, software, or energy sources.
Indications for Use
Indicated for patients at risk of self-injury or interruption of medical care requiring physical restraint to a bed or chair.
Regulatory Classification
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.
Predicate Devices
- Posey Waist & Chest Vest (J.T. Posey Company)
- Posey Criss-Cross Vest (J.T. Posey Company)
- Posey-Van Pelt Limb Holder (J.T. Posey Company)
- Posey Economy Limb Holder (J.T. Posey Company)
Related Devices
- K963393 — MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT · Depuy, Inc. · Oct 31, 1996
- K963431 — POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER · Zimmer, Inc. · Nov 6, 1996
- K963413 — MULTIPLE LIMB HOLDERS · J. T. Posey Co. · Nov 14, 1996
- K963478 — SLEEVED/SLEEVELESS VEST RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996
- K963471 — SUPER SECURITY RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996
Submission Summary (Full Text)
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K 962429
# Summary of Safety & Effectiveness Data for the Johnson & Johnson Safety Vests
Johnson & Johnson Professional, Inc.
325 Paramount Drive
Raynham, Massachusetts 02767
1. Contact Person
Johanna Adler, Assoc. Regulatory Affairs Specialist, (508) 828-3268.
2. Device Name
Proprietary Name: Johnson & Johnson Safety Vests
Common Name: Safety Vests
Classification Name: Protective Restraint
Regulatory Class: Class I by 21 CFR § 880.6760
Product Code: 80 FMQ
Owner/Operator # 9001269
3. Device Classification
Classification for Johnson & Johnson Safety Vests has been placed in Class I by 21 CFR § 880.6760
4. Statement of Substantial Equivalence
The safety and effectiveness of the Johnson & Johnson Safety Vest and the Safety Vest Poncho Style is substantiated by its similarity in design, characteristics, and indications for use, to the currently marketed Posey Waist & Chest Vest and the Posey Criss-Cross Vest, by J.T. Posey Company.
5. Indications for Use
The Johnson & Johnson Safety Vests are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them. These products can be used in restraining patients to a bed or chair.
6. Physical Description
The Johnson & Johnson Safety Vests are constructed of lightweight nylon mesh with webbed tie straps and shoulder loops. These vests may be attached to either a chair or a bed.
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K962429
# Summary of Safety & Effectiveness Data for the Johnson & Johnson Limb Holders
Johnson & Johnson Professional, Inc.
325 Paramount Drive
Raynham, Massachusetts 02767
## 1. Contact Person
Johanna Adler, Assoc. Regulatory Affairs Specialist, (508) 828-3268.
## 2. Device Name
| Proprietary Name: | Johnson & Johnson Limb Holders |
| --- | --- |
| Common Name: | Limb Holders |
| Classification Name: | Protective Restraint |
| Regulatory Class: | Class I by 21 CFR § 880.6760 |
| Product Code: | 80 FMQ |
| Owner/Operator # | 9001269 |
## 3. Device Classification
Classification for Johnson & Johnson Limb Holders has been placed in Class I by 21 CFR § 880.6760
## 4. Statement of Substantial Equivalence
The safety and effectiveness of the Johnson & Johnson Canvas Limb Holder and the Economy Limb Holder is substantiated by its similarity in design, technological characteristics, and indications for use, to the currently marketed Posey-Van Pelt Limb Holder and the Posey Economy Limb Holder, by J.T. Posey Company.
## 5. Indications for Use
The Johnson & Johnson Limb Holders are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them. These products can be used in restraining patients to a bed or chair.
## 6. Physical Description
The Johnson & Johnson Canvas Limb Holder is constructed of a cotton canvas wrist protector with a soft cotton lining, and a polyester strap. The Economy Limb Holder is constructed of a nylon laminated foam with hook and loop closure and polyester straps.
