# K202395: SP-1000, SP-2000

- Pathway: 510(k) (Traditional)
- Applicant: Daesung Maref Co., Ltd.
- Decided: Sep 1, 2021 after 376 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.
No later device cites it as a predicate yet.
0 of 20 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 4.

## Indications for use
SP-1000/2000 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.

Source page: https://510kreport.com/device/K202395
Methodology: https://510kreport.com/methodology