Cleared Traditional

R-C1 TENS and EMS Stimulator (K181688) - FDA 510(k) Clearance

Also marketed or referenced as:
R-E1- EMS Stimulator R-T1 TENS Stimulator

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

K181688 · Shenzhen Roundwhale Technology Co. , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
73d
Days
Class 2
Risk

K181688 is an FDA 510(k) clearance for the R-C1 TENS and EMS Stimulator. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Shenzhen Roundwhale Technology Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 7, 2018 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Roundwhale Technology Co. , Ltd. devices

Submission Details

510(k) Number K181688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2018
Decision Date September 07, 2018
Days to Decision 73 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
42d faster than avg
Panel avg: 115d · This submission: 73d
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 73
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K181688.
geko T-2 and geko T-3 Neuromuscular Stimulators
K191113 · Firstkind Limited · Sep 2019
Shear Stress Therapeutics SST 3000
K182163 · Shear Stress Therapeutics, LLC · Jul 2019
PowerDot PD-01MT
K181759 · Smartmissimo Technologies Pte, Ltd. · Nov 2018
geko T-3 Neuromuscular Stimulator
K181059 · Firstkind Limited · May 2018
Digitimer DS7AP Constant Current Stimulator
K172381 · Digitimer , Ltd. · Mar 2018
geko T-2 and geko Plus R-2
K180082 · Firstkind, Ltd. · Feb 2018