Cleared Traditional

Digitimer DS7AP Constant Current Stimulator (K172381) - FDA 510(k) Clearance

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

K172381 · Digitimer , Ltd. · Physical Medicine device
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Mar 2018
Decision
211d
Days
Class 2
Risk

K172381 is an FDA 510(k) clearance for the Digitimer DS7AP Constant Current Stimulator. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Digitimer , Ltd. (Welwyn Garden City, GB). The FDA issued a Cleared decision on March 6, 2018 after a review of 211 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 Digitimer , Ltd. devices

Submission Details

510(k) Number K172381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2017
Decision Date March 06, 2018
Days to Decision 211 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
96d slower than avg
Panel avg: 115d · This submission: 211d
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 K172381.
PowerDot PD-01MT
K181759 · Smartmissimo Technologies Pte, Ltd. · Nov 2018
R-C1 TENS and EMS Stimulator
K181688 · Shenzhen Roundwhale Technology Co. , Ltd. · Sep 2018
geko T-3 Neuromuscular Stimulator
K181059 · Firstkind Limited · May 2018
geko T-2 and geko Plus R-2
K180082 · Firstkind, Ltd. · Feb 2018
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
K171978 · Shenzhen Dongdixin Technology Co., Ltd. · Oct 2017
HPM-6000
K160992 · BTL Industries, Inc. · Oct 2016