Restraint, Protective

FDA product code FMQ · 134 cleared devices

Class 1 General Hospital

Regulation: 21 CFR 880.6760
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-11-24 – 2011-04-25

FMQ 1996-10-16

STRAIT JACKET

Applicant Deroyal Industries, Inc.

K number K963463

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FMQ 1996-10-11

HEELBO WRAP AROUND VEST

Applicant Heelbo, Inc.

K number K963294

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FMQ 1996-10-09

ROLL BELT

Applicant Skil-Care Corp.

K number K963460

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FMQ 1996-10-09

SLEEPER JACKET/HOUDINI SAFETY SLEEPER

Applicant Skil-Care Corp.

K number K963457

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FMQ 1996-10-09

HEELBO ICU 911 BLAZER SLEEVED JACKET

Applicant Heelbo, Inc.

K number K963237

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FMQ 1996-10-09

HEELBO QUILTED TORSO RESTRAINT

Applicant Hollister, Inc.

K number K963108

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FMQ 1996-10-09

GREAT HANDS MITTS

Applicant Heelbo, Inc.

K number K962810

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FMQ 1996-10-09

THE L-BOW ARM RESTRAINT

Applicant Heelbo, Inc.

K number K962778

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FMQ 1996-10-08

LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER

Applicant Skil-Care Corp.

K number K963456

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FMQ 1996-10-07

CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT

Applicant Skil-Care Corp.

K number K963454

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FMQ 1996-10-07

SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST

Applicant Skil-Care Corp.

K number K963450

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FMQ 1996-10-07

PELVIC HOLDER

Applicant Skil-Care Corp.

K number K963449

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FMQ 1996-10-07

ECONO BELT

Applicant Skil-Care Corp.

K number K963448

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FMQ 1996-10-07

DOUBLE SUPPORT PONCHO/SLIDER PONCHO

Applicant Skil-Care Corp.

K number K963447

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FMQ 1996-10-02

PATIENT PROTECTIVE LIMB

Applicant Kenad SG Medical, Inc.

K number K962626

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FMQ 1996-10-01

HEELBO BLAZER SLEEVED JACKET

Applicant Heelbo, Inc.

K number K963243

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FMQ 1996-09-18

SAFETY VEST

Applicant Johnson & Johnson Professionals, Inc.

K number K962429

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FMQ 1993-04-08

NEAL WRIST CONES

Applicant Neal & Assoc., Inc.

K number K925924

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FMQ 1985-04-01

BED PRODUCTS

Applicant Abco Dealers, Inc.

K number K850470

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FMQ 1981-12-02

HEAD PROTECTOR

Applicant Maddak, Inc.

K number K812473

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FMQ 1980-06-17

TECNOL QUICK RELEASE LIMB HOLDER

Applicant Tecnol New Jersey Wound Care, Inc.

K number K801272

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FMQ 1979-10-26

SKIL-CARE SUPER-SOFT LIMB RESTRAINTS

Applicant Skil-Care Corp.

K number K792012

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FMQ 1979-06-01

TECNOL BODY HOLDER

Applicant Tecnol New Jersey Wound Care, Inc.

K number K790699

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FMQ 1979-02-27

BK-5098 TILT TABLE STRAP

Applicant Fred Sammons, Inc.

K number K790172

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FMQ 1978-02-21