FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K963527

Device Name

UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS

Manufacturer

ALIMED, INC.

Date Cleared

1996-10-31

(57 days)

Product Code

FMQ

Regulation Number

880.6760

Intended Use

Reduce patient movement in recover, in bed, or other uses as determined by the health care professiona user.

Device Description

The devices are fabricated using nylon or nylon and polyethol foam of various lengths and widths as described in advertising. The closure is Velcro® or Velcro®-like hook and loop.

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K Number

K963528

Device Name

ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)

Manufacturer

ALIMED, INC.

Date Cleared

1996-10-29

(55 days)

Product Code

FMQ

Regulation Number

880.6760

Intended Use

Reduction of patient movement, or restrain of patient, during medical procedure, during transportation of the patient, or in other situation s deemed appropriate by the health car facility.

Device Description

The devices are fabricated various lengths and widths as described in advertising. The closure is "hook and loop".

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K Number

K963526

Device Name

STRAP WEDGE

Manufacturer

ALIMED, INC.

Date Cleared

1996-10-28