# K222949: Air Compression Leg Massager (Model: LY-670D)

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Luyao Electronics Technology Co., Ltd.
- Decided: Dec 22, 2022 after 86 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: 1 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 17, 2025 · Class II · Z-2463-2025: Regulatory documentation error and misleading color packaging claim.

## Indications for use
The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Source page: https://510kreport.com/device/K222949
Methodology: https://510kreport.com/methodology
