510(k) Report

FDA applicant

Manamed, Inc.

Las Vegas, NV9 decisions2016–20260 recalls

FDA records 9 decisions for Manamed, Inc. (Las Vegas, NV) from 2016 to 2026: 9 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and IMI (Ultrasonic Diathermy For Use In Applying…). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Manamed, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Manamed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12020: 22021: 12022: 12023: 22025: 12026 (partial year): 1
2016high 2 (2020) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Manamed, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Manamed, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JOWSleeve, Limb, Compressible4decisions
  • IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat2decisions
  • IRPMassager, Powered Inflatable Tube2decisions
  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 142 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 4 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K160318PlasmaFlowManamed, Inc. · 20163cite it
  • K222098ManaSport+Manamed, Inc. · 20231cites it
  • K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 20231cites it
  • K210284ManaSportManamed, Inc. · 20221cites it
  • K200351PlasmaFlightManamed, Inc. · 20201cites it
  • K200353ManaFlowManamed, Inc. · 20201cites it

What has FDA decided for it lately?

  • K260944ManaCold Compression SystemManamed, LLC · 2026
  • K251446PlasmaFlow X Compression Sleeve Device (XPF0001)Manamed, LLC · 2025
  • K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 2023
  • K222098ManaSport+Manamed, Inc. · 2023
  • K210284ManaSportManamed, Inc. · 2022
  • K211253PlasmaWaveManamed, Inc. · 2021
  • K200353ManaFlowManamed, Inc. · 2020
  • K200351PlasmaFlightManamed, Inc. · 2020

All 7 as Manamed, Inc. →All 2 as Manamed, LLC →