# K963528: Alimed Positioning 7 Safety Straps (Three Types), Universal CR/Mri Wide Body Strap, Universal CT Scanner Strap (2 Sizes)

- Pathway: 510(k) (Traditional)
- Applicant: Alimed, Inc.
- Decided: Oct 29, 1996 after 55 days
- Product code: FMQ (Restraint, Protective)
- Device class: 1
- Regulation: 21 CFR 880.6760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Various Preamendments straps and restraints: named in the summary without a submission number

## Indications for use
Reduction of patient movement, or restrain of patient, during medical procedure, during transportation of the patient, or in other situations deemed appropriate by the health care facility.

Source page: https://510kreport.com/device/K963528
Methodology: https://510kreport.com/methodology