(81 days)
The devices included in this 510(k) submission provide anterior postural support. The products are closed around the wheelchair by hook and loop straps. An optional strap can be secured behind the patient to prevent the tray from being pushed forward. 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 included in this 510(k) submission provide anterior postural support. The products are closed around the wheelchair by hook and loop straps. An optional strap can be secured behind the patient to prevent the tray from being pushed forward. If the patient cannot easily self release the product, it may be considered a restraint.
This document is a 510(k) premarket notification for "Posey® Laptop Trays." It does not contain information about an AI/ML powered medical device, an associated study, or acceptance criteria related to a device's performance characteristics.
The document discusses:
- The device: Posey® Laptop Trays, designed for anterior postural support and a surface for activities for wheelchair users.
- Regulatory context: The submission is in response to a new FDA rule requiring 510(k) notification for protective restraints, specifically revoking exemptions for devices like these.
- Predicate device: The "devices used for comparative purposes are identical to the laptop trays as described in this submission and produced or sold by the J.T. Posey Co." This indicates that the comparison is against their own legally marketed products that were previously exempt, not against a different type of device or technology.
Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving a device meets them, as this submission is for a traditional medical device and not an AI/ML powered one.
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J. T. Poseu Co.
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. I. Posey Co.
Customer Service
Toll Free: (800) 44-POSEY
Tel: (818) 443-3143
Fax: (818) 443-5014
SAFETY AND EFFECTIVENESS SUMMARY
5635 Peck Road · Arcadia, California 91006-0020 U.S.A
NOV 1 9 1996
JT Posey Company 5635 Peck Road Arcadia, CA 91006 Michael Keefe General Manager August 30, 1996 Revised: November 18, 1996
Phone # (818) 443-3143 FAX # (818) 443-5014
Reference Number: K963411
Trade Name: Posey® Laptop Trays Common Name: Laptop Trays Classification Name: Protective Restraints
The devices included in this 510(k) submission provide anterior postural support. The products are closed around the wheelchair by hook and loop straps. An optional strap can be secured behind the patient to prevent the tray from being pushed forward. 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 laptop trays as described in this submission and produced or sold by the J.T. Posey Co. This premarket submission is submitted in response to the agency's final rule published on March 4. 1996 in the Federal Register 21 CFR 880 and 21 CFR 890 Medical Devices, Protective Restraints - Revocation of Exemptions from 510(k) Pre-market Notification Procedures and Current Good Manufacturing Practice Repulation. The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale for which devices would be used for comparison:
"Predicate device
FDA indicated that it would be appropriate for manufacturers to reference their current products as legally marketed devices for companson purposes in their submissions. It would also be appropriate to reference any approved 5.10(k)s that manufacturers have submitted for their products."
The laptop trays are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Co. as of the date of this submission, August 30,1996. The limb holders have been manufactured and in commercial distribution for up to 20 years.
§ 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.