# K201982: Air compression therapy system FO-3001; Air compression therapy system FO-3008

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Hongfeng Co., Ltd.
- Decided: Mar 25, 2021 after 251 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: 7 generations back to K850316 (1985). 18 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160608: NormaTec Pulse and NormaTec Pulse Pro, NormaTec Industries, LP (2016) Summary page 6.

## Most influential descendants
- K230500: Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) (2023), 1 descendant of its own
- K260948: Air Compression Massager (EP30B001 I) (2026), 0 descendants of its own
- K251531: Air Compression Boots 1018195,1018196 (2025), 0 descendants of its own

## Indications for use
Air compression therapy system Models FO-3001 and FO-3008: Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in the treated areas.

Source page: https://510kreport.com/device/K201982
Methodology: https://510kreport.com/methodology