510(k) Report

FDA applicant

Cymedica Orthopedics, Inc.

Scottsdale, AZ5 decisions2015–20230 recalls

FDA records 5 decisions for Cymedica Orthopedics, Inc. (Scottsdale, AZ) from 2015 to 2023: 5 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GXY (Electrode, Cutaneous). Since 2016 its 510(k)s took a median of 44 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

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 Cymedica Orthopedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015: 12016: 12021: 12022: 12023: 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Cymedica Orthopedics, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cymedica Orthopedics, 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?

  • IPFStimulator, Muscle, Powered4decisions
  • GXYElectrode, Cutaneous1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 44 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 20162cite it
  • K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc. · 20152cite it
  • K210604Intellihab SystemCymedica Orthopedics, Inc. · 20211cites it

What has FDA decided for it lately?

  • K230533Motive™ ElectrodeCymedica Orthopedics, Inc. · 2023
  • K220738Motive Knee WrapCymedica Orthopedics, Inc. · 2022
  • K210604Intellihab SystemCymedica Orthopedics, Inc. · 2021
  • K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016
  • K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc. · 2015

All 5 as Cymedica Orthopedics, Inc. →