Cleared Traditional

K994265 - MEDISANA DIGITAL TENS

K994265 is an FDA 510(k) clearance for MEDISANA DIGITAL TENS, manufactured by Fuji Dynamics Limited. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K994265 · Fuji Dynamics Limited · Neurology device
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Jul 2000
Decision
202d
Days
Class 2
Risk

K994265 is an FDA 510(k) clearance for the MEDISANA DIGITAL TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Fuji Dynamics Limited (Kowloon, HK). The FDA issued a Cleared decision on July 6, 2000 after a review of 202 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K994265

510(k) Number K994265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1999
Decision Date July 06, 2000
Days to Decision 202 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 149d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 449
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K994265.
STIMATE N601 TENS
K003487 · Everyway Medical Instruments Co.,Ltd · Jan 2001
HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3
K003231 · Home Medical Services · Jan 2001
MS-ONE, MODEL MS-1
K003258 · Home Wellness West · Jan 2001
FDTENS 2010
K994266 · Fuji Dynamics Limited · Jul 2000
ENDOR 2000
K984376 · T.C. Medical, Inc. · Jun 2000
RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
K994387 · Woodside Biomedical, Inc. · Mar 2000
K994265 · MEDISANA DIGITAL TENS
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