Cleared Traditional

Shoulder Pacemaker (K210674) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210674 · Ncs Lab Srl · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
172d
Days
Class 2
Risk

K210674 is an FDA 510(k) clearance for the Shoulder Pacemaker. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Ncs Lab Srl (Carpi, IT). The FDA issued a Cleared decision on August 24, 2021 after a review of 172 days - an extended review cycle.

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 Ncs Lab Srl devices

Submission Details

510(k) Number K210674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2021
Decision Date August 24, 2021
Days to Decision 172 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 115d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 72
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K210674.
geko W-2
K212762 · Firstkind Limited · Nov 2021
MyoWorx TM20
K192746 · Myoworx, Inc. · Oct 2021
STELLA BIO
K210002 · Egzotech Sp. Z O. O. · Oct 2021
PowerDot PD-01MT2 Muscle Stimulator
K210938 · Smartmissimo Technologies Pte, Ltd. · Jul 2021
Nerve and Muscle Stimulator
K211094 · Shenzhen Xft Medical Limited · Jul 2021
Intellihab System
K210604 · Cymedica Orthopedics, Inc. · Jun 2021