Cleared Traditional

K982961 - MEDIPOINT

K982961 is an FDA 510(k) clearance for MEDIPOINT, manufactured by Medipoint , Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K982961 · Medipoint , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
287d
Days
Class 2
Risk

K982961 is an FDA 510(k) clearance for the MEDIPOINT. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medipoint , Ltd. (New York, US). The FDA issued a Cleared decision on June 7, 1999 after a review of 287 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.

View all Medipoint , Ltd. devices

FDA 510(k) Submission Details - K982961

510(k) Number K982961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1998
Decision Date June 07, 1999
Days to Decision 287 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 148d · This submission: 287d
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 232
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K982961.
MED-4000
K993823 · Micro Current Technology, Inc. · Nov 1999
1818 TENS UNIT
K992709 · 138 Medical Supplies, Inc. · Nov 1999
ELECTRO-NERVE STIMULATOR TENS, MODEL LX
K990230 · Biomedical Life Systems, Inc. · Aug 1999
BUZBEE
K982173 · Mwr Electronics Industrial Co. · Mar 1999
RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R
K982967 · Woodside Biomedical, Inc. · Feb 1999
CARE TENS
K984025 · Care Rehab, Inc. · Feb 1999