Panels › General Hospital › Product code FMQ · Class 1
Restraint, Protective
Regulation 880.6760
0510(k)s in 12 months (134 all time)
0recalls in 12 months (33 all time)
25recalls that name a 510(k)
Top companies in FMQ
| Company | 510(k)s | Recalls |
|---|---|---|
| J. T. Posey Co. | 9 | 25 |
| Deroyal Industries, Inc. | 15 | 3 |
| Heelbo, Inc. | 14 | 0 |
| Skil-Care Corp. | 12 | 0 |
| Tecnol Medical Products, Inc. | 9 | 0 |
| Morrison Medical Products | 8 | 0 |
| Medical Restraints, Inc. | 7 | 0 |
| Medline Industries, Inc. | 5 | 0 |
| Fla Orthopedics, Inc. | 4 | 0 |
| Hollister, Inc. | 4 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2022 | DeRoyal Industries Inc DeRoyal limb holders:
(1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124;
(2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125;
(3) DeRoyal Security Cuffs, Wrist and Ankle, Un Terminated |
FMQ | None listed |
| Aug 18, 2021 | Queen Comfort Products lLC COVENA PICC Sleeve Terminated |
FMQ | None listed |
| Feb 27, 2020 | DeRoyal Industries Inc DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint. Terminated |
FMQ | None listed |
| Apr 12, 2019 | TIDI PRODUCTS Posey Connected Twice-As-Tough Cuffs Terminated |
FMQ | None listed |
| Sep 14, 2015 | Med Tec Inc CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX.
For use in patient positioning. The grips are used for pulling down the shoulders during radiother Terminated |
FMQ | None listed |
| Jan 15, 2015 | Med Tec Inc Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx
The devise is intended to Terminated |
FMQ | None listed |
| Jan 15, 2015 | Med Tec Inc Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only,
The devise is intended to pull patients shoulders down for c Terminated |
FMQ | None listed |
| Mar 14, 2014 | DeRoyal Industries Inc DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017
Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/o Terminated |
FMQ | K963476 |
| Apr 9, 2013 | J T Posey Company Posey Biothane Restraint Cuffs, Catalog Number 2900.
The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others. Terminated |
FMQ | None listed |
| Sep 22, 2009 | J T Posey Company Posey Swedish Belt (1337).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Special Order, Posey Connected Twice-As-Tough Cuffs, Ankle (for use on the bed) (S27957).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examinatio Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Special Order, Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (S27947).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination o Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Locking Twice-As Tough Ambulatory Belt (2800).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or oth Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Locking Twice-As Tough Cuffs, Ankles (lock on cuff and strap) (2799).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protectio Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Locking Twice-As Tough Cuffs, Wrists (lock on cuff & strap) (2798).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connected Twice-As Tough Cuffs, Ankles (for use on bed) (2795).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of t Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (2794).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of t Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Locking Twice-As Tough Cuffs, Ankles (lock on strap) (2793).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Locking Twice-As Tough Cuffs, Wrists (lock on strap) (2792).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connecting Strap/Belt, Polypropylene, 72" (235072).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient o Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connecting Strap/Belt, Polypropylene, 60" (235060).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient o Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connecting Strap/Belt, Polypropylene, 48" (235048).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient o Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connecting Strap/Belt, Polypropylene, 36" (235036).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient o Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connecting Strap/Belt, Polypropylene, 24" (235024).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient o Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connecting Strap/Belt, Polypropylene, 18" (235018).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient o Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connecting Strap/Belt, Cotton, 72" (232072).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or other Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connecting Strap/Belt, Cotton, 60" (232060).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or other Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connecting Strap/Belt, Cotton, 48" (232048).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or other Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Connecting Strap/Belt, Cotton, 36" (232036).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or other Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Fifth Point Restraint, Locking (2219L).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Terminated |
FMQ | K963436 |
| Sep 22, 2009 | J T Posey Company Posey Key Lock Belt (1334).
Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.. Terminated |
FMQ | K963436 |
| Feb 3, 2009 | J T Posey Company Posey Connecting Straps & Belts/Locking Cuffs.
The device is used to limit the wearer's movement by securing cuffs to a connecting strap or belt. Terminated |
FMQ | K963413 |
| Dec 2, 2008 | J T Posey Company Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B Terminated |
FMQ | K963413 |
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