Cleared Traditional

K122812 - JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS

K122812 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
210d
Days
-
Risk

K122812 is an FDA 510(k) clearance for the JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS. 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 April 11, 2013 after a review of 210 days - an extended review cycle.

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 - K122812

510(k) Number K122812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2012
Decision Date April 11, 2013
Days to Decision 210 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
61d slower than avg
Panel avg: 149d · This submission: 210d
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 K122812.
Electro Auricular Device
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K130768 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2013
MULTI-PURPOSE HEALTH DEVICE
K093322 · Upc Medical Supplies, Inc. Dba United Pacific Co. · Aug 2010
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K091933 · Inno-Health Technology, Inc. · Apr 2010
E-PULSE
K091875 · Medevice Corporation · Dec 2009