Cleared Traditional

K130768 - JIAJIAN CMN STIMULATOR

K130768 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
149d
Days
-
Risk

K130768 is an FDA 510(k) clearance for the JIAJIAN CMN STIMULATOR. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 16, 2013 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. 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 Wuxi Jiajian Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K130768

510(k) Number K130768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2013
Decision Date August 16, 2013
Days to Decision 149 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
At panel average
Panel avg: 149d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Peers - BWK Stimulator, Electro-acupuncture

All 18
Devices cleared under the same product code (BWK) and FDA review panel - the closest regulatory comparables to K130768.
PANTHEON ELECTROSTIMULATOR
K133980 · Pantheon Research · Nov 2014
Electro Auricular Device
K140530 · Navigant Consulting, Inc. · Oct 2014
P-STIM
K140788 · Biegler GmbH · Jun 2014
JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
K122812 · Wuxi Jiajian Medical Instrument Co., Ltd. · Apr 2013
MULTI-PURPOSE HEALTH DEVICE
K093322 · Upc Medical Supplies, Inc. Dba United Pacific Co. · Aug 2010
ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
K091933 · Inno-Health Technology, Inc. · Apr 2010