# K210281: Fist Assist Devices Model FA-1

- Pathway: 510(k) (Traditional)
- Applicant: Fist Assist Devices, LLC
- Decided: Jun 17, 2021 after 136 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). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183169: Pulse 2.0, Pulse Pro 2.0, NormaTec Industries, LP (2018) Summary page 4.
- K122154: Powerplay Muscle Massager, Fig, LLC (2012) Summary page 4.
- K200351: PlasmaFlight, Manamed, Inc. (2020) Summary page 4.

## Indications for use
The Fist Assist Model FA-1 is an arm massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Source page: https://510kreport.com/device/K210281
Methodology: https://510kreport.com/methodology