(76 days)
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No
The provided text describes a simple mechanical device for postural support in a wheelchair and contains no mention of AI, ML, or related concepts.
No
The text explicitly states the device provides "postural support and a surface for activities," which are functional aids, not therapeutic interventions aimed at treating a disease or condition. It also mentions it could be a "restraint."
No
The device is described as providing "anterior postural support" and a "surface for activities," and also notes it "may be considered a restraint." These descriptions indicate a physical support or assistive device, not one used for diagnosis. There is no mention of detecting, analyzing, or identifying medical conditions or diseases.
No
The device description clearly indicates a physical product ("inserted into the arms of the wheelchair compressing the foam") which is a hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to provide anterior postural support and a surface for activities in a wheelchair. This is a physical support function, not a diagnostic test performed on biological samples.
- Device Description: The description details a physical product inserted into a wheelchair for support. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD-related terms: The text does not contain any terms typically associated with IVDs, such as "in vitro," "diagnostic," "assay," "reagent," "sample," "analyte," etc.
Therefore, the device described is a medical device for physical support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These products are intended to provide postural support and a surface for activities,
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The devices included in this 510(k) submission provide anterior postural support, The products are inserted into the arms of the wheelchair compressing the foam and releasing it once in position.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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): 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.
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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.
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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).
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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.
0
J. T. Posey Co.
Posev Con
818 443 5064 P. 02/03
Customer Service
Toll Free: (800) 44-PC
Tel: (818) 443-314
Fax: (618) 443-501
5635 Peck Road · Arcadia, California 91006-0020 U.S.A.
NOV 14 1996
SAFETY AND EFFECTIVENESS SUMMARY
JT Posey Company 5635 Peck Road Arcadia, CA 91006 Michael Keefe General Manager August 30, 1996 Revised: November 13, 1996
Phone # (818) 443-3143 FAX # (818) 443-5014
Reference Number: K963409
Trade Name: Posey® Hugger Common Name: Hugger Classification Name: Wheelchair Accessory
The devices included in this 510(k) submission provide anterior postural support, The products are inserted into the arms of the wheelchair compressing the foam and releasing it once in position. If the patient cannot easily self release the product, it may be considered a restraint.
These products are intended to provide postural support and a surface for activities,
The devices used for comparative purposes are identical to the huggers as described in this submission and produced or sold by the J.T. Posey Co. The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale for which devices would be used for companson:
"Predicate device
FDA indicated that it would be appropriate for manufacturers to reference their current products as legally marketed devices for comparison purposes in their submissions. It would also be appropriate to reference any approved 510(k)s that manufacturers have submitted for their products."
The huggers are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Company as of the date of this submission, August 30,1996.