# K193354: Air Compression Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongjilian Electronics Co., Ltd.
- Decided: Jun 8, 2020 after 187 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K850316 (1985). 19 ancestors in all.
20 later devices descend from it; 9 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182668: Rapid Reboot Compression Therapy System, Rapid Reboot Recovery Products, LLC (2018) Summary page 5.
- K030437: Relaxor Perfect Touch Air Massaging System, Salton, Inc. (2003) Summary page 5.
- K160608: NormaTec Pulse and NormaTec Pulse Pro, NormaTec Industries, LP (2016) Summary page 5.

## Most influential descendants
- K213745: Air Compression Therapy Device, model: ST-502 (2022), 3 descendants of its own
- K232965: Leg Massager (Models:RP-ALM070H, RP-ALM071H) (2024), 2 descendants of its own
- K222991: Air Compression Leg Massager (model: EMK-701) (2023), 2 descendants of its own
- K222669: Cryopush Cold Compression Device (2022), 2 descendants of its own
- K221666: Normatec Go (2022), 2 descendants of its own

## Indications for use
The Air Compression Therapy Device 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 Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

Source page: https://510kreport.com/device/K193354
Methodology: https://510kreport.com/methodology