Atlas FDA

RESTRAINT ACCESSORIES

FDA 510(k) clearance K963436 · decided 1996-11-22

Clearance details

K-number
K963436
Device name
RESTRAINT ACCESSORIES
Applicant
J. T. Posey Co.
Decision
Substantially Equivalent
Date received
1996-08-30
Decision date
1996-11-22
Days to decision
84 days
Clearance type
Traditional
Product code
FMQ
Device class
1
Regulation number
880.6760
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Arcadia, CA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
PROTECTIVE RESTRAINT (K110377)Medi-Tech Intl. Corp.2011-04-25
STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 (K081264)Children'S Health First, Inc.2009-02-13
CENTURION PROTECTIVE RESTRAINT, SCR SERIES (K080448)Tri-State Hospital Supply Corp.2008-08-28
COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES (K013239)Med Gen, Inc.2001-11-20
INFANT LIMB HOLDER, MODELS 306080 & 306081 (K010818)Skil-Care Corp.2001-05-24
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (K010644)Skil-Care Corp.2001-05-18
BIOTHANE PATIENT RESTRAINT (K991591)Bioplastics1999-07-29
VAGABOND SOFT RESTRAINT SYSTEM (K982178)Emergent Innovations, Ltd.1999-01-26
HEELBO WAIST AND CHEST VEST (K980640)Heelbo, Inc.1998-05-01
PEDO CUSH PEDO CUDDLE (K972446)Cavity Free Kids, Inc.1997-11-13
FULL BODY RESTRAINT SYSTEM (K972046)Gillen Industries1997-08-15
PATIENT RESTRAINT (K971948)E.M. Adams Co., Inc.1997-08-06

Recalls involving this device

RecordFirmDate
Posey Key Lock Belt (1334). Intended for medical purposes to limit a patient's movement to recall (Z-2254-2009)J T Posey Company2009-09-22
Posey Fifth Point Restraint, Locking (2219L). Intended for medical purposes to limit a pat recall (Z-2255-2009)J T Posey Company2009-09-22
Posey Connecting Strap/Belt, Cotton, 36" (232036). Intended for medical purposes to limit recall (Z-2256-2009)J T Posey Company2009-09-22
Posey Connecting Strap/Belt, Cotton, 48" (232048). Intended for medical purposes to limit recall (Z-2257-2009)J T Posey Company2009-09-22
Posey Connecting Strap/Belt, Cotton, 60" (232060). Intended for medical purposes to limit recall (Z-2258-2009)J T Posey Company2009-09-22
Posey Connecting Strap/Belt, Cotton, 72" (232072). Intended for medical purposes to limit recall (Z-2259-2009)J T Posey Company2009-09-22
Posey Connecting Strap/Belt, Polypropylene, 18" (235018). Intended for medical purposes to recall (Z-2260-2009)J T Posey Company2009-09-22
Posey Connecting Strap/Belt, Polypropylene, 24" (235024). Intended for medical purposes to recall (Z-2261-2009)J T Posey Company2009-09-22
Posey Connecting Strap/Belt, Polypropylene, 36" (235036). Intended for medical purposes to recall (Z-2262-2009)J T Posey Company2009-09-22
Posey Connecting Strap/Belt, Polypropylene, 48" (235048). Intended for medical purposes to recall (Z-2263-2009)J T Posey Company2009-09-22
Posey Connecting Strap/Belt, Polypropylene, 60" (235060). Intended for medical purposes to recall (Z-2264-2009)J T Posey Company2009-09-22
Posey Connecting Strap/Belt, Polypropylene, 72" (235072). Intended for medical purposes to recall (Z-2265-2009)J T Posey Company2009-09-22
Posey Locking Twice-As Tough Cuffs, Wrists (lock on strap) (2792). Intended for medical pu recall (Z-2266-2009)J T Posey Company2009-09-22
Posey Locking Twice-As Tough Cuffs, Ankles (lock on strap) (2793). Intended for medical pu recall (Z-2267-2009)J T Posey Company2009-09-22
Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (2794). Intended for medical recall (Z-2268-2009)J T Posey Company2009-09-22
Posey Connected Twice-As Tough Cuffs, Ankles (for use on bed) (2795). Intended for medical recall (Z-2269-2009)J T Posey Company2009-09-22
Posey Locking Twice-As Tough Cuffs, Wrists (lock on cuff & strap) (2798). Intended for med recall (Z-2270-2009)J T Posey Company2009-09-22
Posey Locking Twice-As Tough Cuffs, Ankles (lock on cuff and strap) (2799). Intended for m recall (Z-2271-2009)J T Posey Company2009-09-22
Posey Locking Twice-As Tough Ambulatory Belt (2800). Intended for medical purposes to limi recall (Z-2272-2009)J T Posey Company2009-09-22
Special Order, Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (S27947). Int recall (Z-2273-2009)J T Posey Company2009-09-22
Special Order, Posey Connected Twice-As-Tough Cuffs, Ankle (for use on the bed) (S27957). recall (Z-2274-2009)J T Posey Company2009-09-22
Posey Swedish Belt (1337). Intended for medical purposes to limit a patient's movement to recall (Z-2275-2009)J T Posey Company2009-09-22