# K160608: NormaTec Pulse and NormaTec Pulse Pro

- Pathway: 510(k) (Traditional)
- Applicant: NormaTec Industries, LP
- Decided: Apr 13, 2016 after 41 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). 17 ancestors in all.
51 later devices descend from it; 8 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112890: Normatec MVP, NormaTec Industries, LP (2012) Summary page 4.
- K122154: Powerplay Muscle Massager, Fig, LLC (2012) Summary page 4.

## Most influential descendants
- K182668: Rapid Reboot Compression Therapy System (2018), 38 descendants of its own
- K193354: Air Compression Therapy Device (2020), 20 descendants of its own
- K183169: Pulse 2.0, Pulse Pro 2.0 (2018), 10 descendants of its own
- K220217: Normatec 3 (2022), 7 descendants of its own
- K201935: Air Pressure Therapy System (2021), 4 descendants of its own

## Indications for use
The NormaTec Pulse and Pulse Pro is an air pressure 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/K160608
Methodology: https://510kreport.com/methodology