# K200351: PlasmaFlight

- Pathway: 510(k) (Traditional)
- Applicant: Manamed, Inc.
- Decided: Aug 5, 2020 after 175 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: 6 generations back to K850316 (1985). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122154: Powerplay Muscle Massager, Fig, LLC (2012) Summary page 4.

## Most influential descendants
- K210281: Fist Assist Devices Model FA-1 (2021), 0 descendants of its own

## Indications for use
The PlasmaFlight is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. This device can be used to: » Temporarily increase blood circulation in the treated areas; » Temporary relief of minor muscle aches and pains.

Source page: https://510kreport.com/device/K200351
Methodology: https://510kreport.com/methodology