Atlas FDA

FMQ

134 FDA 510(k) clearances · Product code

72 daysmedian time to decision
89 days90th percentile
134clearances measured

FDA profile

Official device name
Restraint, Protective
Device class
Class I (low risk)
Regulation
21 CFR 880.6760
Medical specialty
General Hospital
Adverse events (MAUDE)
2020: 38 · 2021: 33 · 2022: 54 · 2023: 47 · 2024: 58 · 2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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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
PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 (K972123)Smith1997-07-25
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT (K971742)Depuy, Inc.1997-07-24
PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. (K972338)Geriatric Products, Inc.1997-07-24
PROVEST-PROTECTIVE RESTRAINT (K971561)Jemm Medical Products1997-07-14
RESTRAINTS (VESTS AND JACKETS) (K971536)E.M. Adams Co., Inc.1997-07-01
PATIENT RESTRAINTS (K970274)Fla Orthopedics, Inc.1997-04-11
PATIENT RESTRAINTS (K970273)Fla Orthopedics, Inc.1997-04-11
PATIENT RESTRAINTS (K970275)Fla Orthopedics, Inc.1997-04-11
PATIENT RESTRAINT (K970272)Fla Orthopedics, Inc.1997-04-11
SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE (K962327)Sekure Seat Corp.1997-03-06
PEDIATRIC LIMB HOLDER (K963466)Deroyal Industries, Inc.1997-02-13
TUXEDO VEST RESTRAINT (K963474)Deroyal Industries, Inc.1997-01-22
RESTRICTIVE LIMB HOLDER (K963468)Deroyal Industries, Inc.1997-01-22
DISPOSABLE LIMB HOLDER (K963476)Deroyal Industries, Inc.1997-01-22
ROLL BELTS (K963467)Deroyal Industries, Inc.1997-01-03
PELVIC HOLDER (K963465)Deroyal Industries, Inc.1996-12-19
PATIENT RESTRAINTS (K963906)Safety Intl., Inc.1996-12-02
THE WRAP IMMOBILIZATION SYSTEM (K963547)Safe Restraints, Inc.1996-12-02
WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) (K963559)Tecnol Medical Products, Inc.1996-11-22
PROTECTIVE RESTRAINT (WAIST HOLDER) (K963421)Kenad SG Medical, Inc.1996-11-22
SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS (K963485)Humane Restraint, Inc.1996-11-22
PROTECTIVE RESTRAINT (PROTECTIVE MITT) (K963422)Kenad SG Medical, Inc.1996-11-22
RESTRAINT ACCESSORIES (K963436)J. T. Posey Co.1996-11-22
POSEY STRAIGHT JACKETS (K963410)J. T. Posey Co.1996-11-22
PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) (K963564)Tecnol Medical Products, Inc.1996-11-22
QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) (K963552)Tecnol Medical Products, Inc.1996-11-22
PROTECTIVE RESTRAINT (VEST RESTRAINT) (K963430)Kenad SG Medical, Inc.1996-11-22
JACKETS AND VESTS (K963442)J. T. Posey Co.1996-11-22
MULTIPLE BELTS (K963414)J. T. Posey Co.1996-11-22
ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040) (K963561)Tecnol Medical Products, Inc.1996-11-21
COMFOR FOAM LIMB HOLDERS- SINGLE STRAP (K963462)Bird & Cronin, Inc.1996-11-21
24448-010 SECURE-ALL FINGER CONTROL MITT (K963554)Tecnol Medical Products, Inc.1996-11-21
SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030 (K963557)Tecnol Medical Products, Inc.1996-11-21
SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030) (K963556)Tecnol Medical Products, Inc.1996-11-21
ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) (K963563)Tecnol Medical Products, Inc.1996-11-21
24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT (K963773)Tecnol Medical Products, Inc.1996-11-21
PEDIATRIC LIMB HOLDERS (K963439)J. T. Posey Co.1996-11-19
POSEY LAPTOP TRAYS (K963411)J. T. Posey Co.1996-11-19
PELVIC HOLDERS (K963437)J. T. Posey Co.1996-11-19
CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) (K963453)Contour Fabricators, Inc.1996-11-15
STUCKEY STRAP-3 FINGER RESTRAINTS (K963491)Stuckey Ent., Inc.1996-11-14
PEDIATRIC VEST RESTRAINT (K963472)Deroyal Industries, Inc.1996-11-14
MITTENS (K963469)Deroyal Industries, Inc.1996-11-14
POSEY HUGGER (K963409)J. T. Posey Co.1996-11-14
SUPER SECURITY RESTRAINT (K963471)Deroyal Industries, Inc.1996-11-14
MULTIPLE LIMB HOLDERS (K963413)J. T. Posey Co.1996-11-14
SLEEVED/SLEEVELESS VEST RESTRAINT (K963478)Deroyal Industries, Inc.1996-11-14
REUSABLE LIMB HOLDER (K963473)Deroyal Industries, Inc.1996-11-14
CRISS-CROSS VEST RESTRAINT (K963470)Deroyal Industries, Inc.1996-11-14
PROTECTIVE RESTRAINT (K963492)Smith and Nephew Donjoy, Inc.1996-11-12
PROTECTIVE RESTRAINT - BELTS (K963490)Smith and Nephew Donjoy, Inc.1996-11-12
WHEEL CHAIR ACCESSORY (K963489)Smith and Nephew Donjoy, Inc.1996-11-12
PEDIATRIC MITTENS (K963477)Deroyal Industries, Inc.1996-11-12
RESTRAINT NET (K963464)Deroyal Industries, Inc.1996-11-12
TORSO/WAIST RESTRAINT (K963374)Morrison Medical Products1996-11-08
DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP (K963387)Morrison Medical Products1996-11-08
CINCH STRAP WITH BUCKLE (K963370)Morrison Medical Products1996-11-08
HEELBO ER WRIST RESTRAINT (K963372)Heelbo, Inc.1996-11-07
BEST STRAP RESTRAINT (K963371)Morrison Medical Products1996-11-07
SPIDER STRAP (K963138)Bdm Medical, Inc.1996-11-06
MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP (K963494)Morrison Medical Products1996-11-06
ANKLE RESTRAINT SYSTEM (K963416)Morrison Medical Products1996-11-06
POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER (K963431)Zimmer, Inc.1996-11-06
ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE (K963435)Zimmer Patient Care Division1996-11-06
MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS (K963399)Morrison Medical Products1996-11-06
HEELBO SECURITY BELT (K963060)Heelbo, Inc.1996-11-04
HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET (K963099)Heelbo, Inc.1996-11-01
HEELBO PELVIC RESTRAINT (K963199)Hollister, Inc.1996-11-01
MORRISON MEDICAL WRIST RESTRAINT (K963419)Morrison Medical Products1996-10-31
MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT (K963393)Depuy, Inc.1996-10-31
UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS (K963527)Alimed, Inc.1996-10-31
HEELBO LIFE JACKET WITH CROTCH SUPPORT (K963041)Heelbo, Inc.1996-10-31
MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER (K963378)Medline Industries, Inc.1996-10-29
MEDLINE OPEN END FINGER CONTROL MITT (K963504)Medline1996-10-29
ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) (K963528)Alimed, Inc.1996-10-29
STRAP WEDGE (K963526)Alimed, Inc.1996-10-28
CHECKMATE ANKLE RESTRAINT SYSTEM (K962963)Hollister, Inc.1996-10-24
HEELBO JOHNNY GRAIT BELT SECURITY BELT (K962964)Hollister, Inc.1996-10-24
WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH (K963569)Medline Industries, Inc.1996-10-18
HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP (K962832)Heelbo, Inc.1996-10-18
MEDLINE PELVIC HOLDER (K963404)Medline Industries, Inc.1996-10-18
PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS (K963458)Skil-Care Corp.1996-10-18
MEDLINE BODY HOLDER (K963360)Medline Industries, Inc.1996-10-18
MEDLINE ZIPPER SLEEVED VEST (K963452)Medline1996-10-18
MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT (K963362)Medline Industries, Inc.1996-10-18
THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE (K962831)Heelbo, Inc.1996-10-18
HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP (K962834)Heelbo, Inc.1996-10-18
HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP (K962839)Heelbo, Inc.1996-10-18
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