# Manamed, Inc.

- Location (FDA's records): Las Vegas, NV
- FDA decisions: 9 (2016–2026): 9 510(k) clearances
- Names in FDA's records: Manamed, Inc. (7); Manamed, LLC (2)
- Product codes: JOW (4), IMI (2), IRP (2), NUH (1)
- 510(k) review time since 2016: median 142 days, against 150 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 8 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ZetrOZ Systems, LLC: 1 (https://510kreport.com/company/zetroz-systems)
- Jkh USA, LLC: 1 (https://510kreport.com/company/jkh-usa)
- Innovamed Health, LLC: 1 (https://510kreport.com/company/innovamed-health)
- Devon Medical, Inc.: 1 (https://510kreport.com/company/devon-medical)
- Fig, LLC: 1 (https://510kreport.com/company/fig)
- Tactile Systems Technology, Inc.: 1 (https://510kreport.com/company/tactile-systems-technology)
- Medi USA, LP: 1 (https://510kreport.com/company/medi-usa)
- Bio Compression Systems, Inc.: 1 (https://510kreport.com/company/bio-compression-systems)

## Firms that cite its devices most
- Jkh Health Co., Ltd.: 2 (https://510kreport.com/company/jkh-health)
- Ortho8, Inc.: 1 (https://510kreport.com/company/ortho8)
- Transtimulation Research, Inc.: 1 (https://510kreport.com/company/transtimulation-research)
- Fist Assist Devices, LLC: 1 (https://510kreport.com/company/fist-assist-devices)

## Its most-cited devices
- K160318: PlasmaFlow (2016), cited by 3
- K222098: ManaSport+ (2023), cited by 1
- K231569: ManaFlexx 2 (model: MF002-RX, MF002-OTC) (2023), cited by 1
- K210284: ManaSport (2022), cited by 1
- K200351: PlasmaFlight (2020), cited by 1
- K200353: ManaFlow (2020), cited by 1

## Recent decisions
- K260944: ManaCold Compression System (Aug 12, 2026)
- K251446: PlasmaFlow X Compression Sleeve Device (XPF0001) (Sep 17, 2025)
- K231569: ManaFlexx 2 (model: MF002-RX, MF002-OTC) (Nov 3, 2023)
- K222098: ManaSport+ (Mar 8, 2023)
- K210284: ManaSport (Apr 26, 2022)
- K211253: PlasmaWave (May 26, 2021)
- K200353: ManaFlow (Aug 6, 2020)
- K200351: PlasmaFlight (Aug 5, 2020)

Source page: https://510kreport.com/company/manamed