Cleared Traditional

K073438 - PROSTIM 1000/2000

K073438 is an FDA 510(k) clearance for PROSTIM 1000/2000, manufactured by Bio Protech, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K073438 · Bio Protech, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
62d
Days
Class 2
Risk

K073438 is an FDA 510(k) clearance for the PROSTIM 1000/2000. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Bio Protech, Inc. (Crofton, US). The FDA issued a Cleared decision on February 7, 2008 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K073438

510(k) Number K073438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2007
Decision Date February 07, 2008
Days to Decision 62 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 149d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 596
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K073438.
AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999
K071120 · Aemed, Inc. · Mar 2008
KFH ENERGY, MODEL: E1
K073008 · Kingfisher Healthcare NV · Mar 2008
TENS/IF 14
K071869 · Emsi · Mar 2008
HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
K072123 · Biowave Corporation · Feb 2008
DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB
K071878 · Med-Lectric Corporation · Dec 2007
EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR
K071624 · Everlife Medical Equipment Co., Ltd. · Nov 2007
K073438 · PROSTIM 1000/2000
Download PDF FDA Summary Bio Protech, Inc.