# K962983: Sterile Soft-Temp

- Pathway: 510(k) (Traditional)
- Applicant: Adroit Medical Systems, Inc.
- Decided: Jan 10, 1997 after 162 days
- Product code: ILO (Pack, Hot Or Cold, Water Circulating)
- Device class: 2
- Regulation: 21 CFR 890.5720
- 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) Soft-Temp hot/cold therapy pads: named in the summary without a submission number

## Indications for use
Sterile Soft-Temp hot/cold therapy pads are intended for use in those situations where a physician determines that hot or cold therapy is necessary.

Source page: https://510kreport.com/device/K962983
Methodology: https://510kreport.com/methodology