K210604 is an FDA 510(k) clearance for the Intellihab System. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.
Submitted by Cymedica Orthopedics, Inc. (Scottsdale, US). The FDA issued a Cleared decision on June 3, 2021 after a review of 94 days - within the typical 510(k) review window.
This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.
View all Cymedica Orthopedics, Inc. devices
NCT04128618
Completed
Interventional
Industry-sponsored
Evaluation of a Home-based NMES Therapy for Knee Osteoarthritis Pain
A Randomized, Sham Controlled, Double-blind, Multi-center Study of Neuromuscular Electrical Stimulation (NMES) as an Adjunctive Therapy for Knee Pain Relief and Improving Functional Outcomes in Knee Osteoarthritis (OA) Patients
| Condition studied |
Knee Osteoarthritis |
| Study design |
Parallel |
| Eligibility |
All sexes
· 21 Years+
· Healthy volunteers accepted
|
| Sponsor |
CyMedica Orthopedics, Inc
(industry)
|
Started 2019-10-08
→
Primary completion 2020-07-30
→
Completed 2020-11-24
Primary outcome
Knee pain using VAS scale (Visual Analog Scale)
Secondary outcome
Timed Up & Go (TUG)
Study completed - no results published.
This trial concluded in 2020 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov