(71 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven features. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as a "poncho style safety vest" intended to provide physical support and prevent falling, not to treat or diagnose a medical condition. Its function is restrictive and supportive, aligning with a restraint rather than a therapeutic intervention.
No
The device is described as a safety vest designed to prevent slumping, sliding, or falling, which are physical support functions, not diagnostic ones.
No
The device description clearly states it is a "poncho style safety vest" made of "polyester/cotton blend" or "polyester mesh material," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Heelbo Waist and Chest Vest is a physical restraint/support device designed to be worn externally on a patient to prevent slumping, sliding, or falling. It does not involve the analysis of biological samples.
The description clearly indicates a physical support device, not a diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMO
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
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
980640
Heelbo.
1134 N. Homan Ave. Chicago, IL 60651
Telex RCA 297-248 800/323-5444
312/489-7711
Fax 312/489-7744
MAY 1 1998
Heelbo. Inc. Waist and Chest Vest
510(k) Summary
1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60048
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 - February 17, 1998
- Name of Device:
Heelbo Waist and Chest Vest
3. Name of Predicate Device(s)
Heelbo Pullover Poncho, K963099 Heelbo Life Jacket Poncho with Crotch Support, K963041 Posey®Waist and Chest Vest
4. Description of Device
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).
5. Statement of Intended Use
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.
1
Heelbo
1134 N. Homan Ave. Chicago. IL 60651
Telex RCA 297-248 800/323-5444
312/489-7711
Fax 312/489-7744
Heelbo. Inc. Waist and Chest Vest
6. Statement of Technological Characteristics of the Device
The proposed device is substantially equivalent to the predicate devices. The following is a chart comparing the devices.
| Characteristics | Heelbo Waist and Chest Vest
(proposed device) | Posey®Waist and Chest Vest
(predicate device) |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Intended Use | 1) help support and help prevent a
patient from slumping or sliding
forward while seated in a wheelchair
or geriatric chair
2) help prevent a patient from falling
out of bed or climbing over slide rails. | Same |
| Materials | Polyester Cotton Blend
Polyester Mesh | Cotton
Breezeline Mesh |
| Number of straps | 2 | 2 |
| Where used | wheelchair, geriatric chair, bed | wheelchair, geriatric chair, bed |
7. Biocompatibility
Materials used in the construction of the proposed device are identical to materials reviewed and cleared under K963099 "Heelbo Pullover Poncho" and K963041 "Heelbo Life Jacket Poncho w/crotch Support." The suppliers of the materials used 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, over a fifteen year period using these materials, Heelbo Inc., is not aware of any adverse biological incidence.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Heelbo Waist and Chest Vest is safe and effective for its intended use and is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, composed of three overlapping profiles facing right. The profiles are rendered in black, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1998
Heelbo, Incorporated C/O Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, Illionis 60048
K980640 Re : Heelbo Waist and Chest Vest Trade Name: Regulatory Class: I Product Code: FMO Dated: February 17, 1998 February 19, 1998 Received:
Dear Mr. Tokarz:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act): You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A ... substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
3
Page 2 - Mr. Tokarz
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Heelbo, Inc. Waist and Chest Vest
Statement of Intended Use
510(k) Number (if Known): Device Name:
K980640 Waist and Chest Vest
Intended Use:
b.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-the-Counter-Use _________________________________________________________________________________________________________________________________________________________
Brenda Burke
(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
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