Cleared Traditional

K220153 - Needle Stimulator (Model: RJNS6-1) (FDA 510(k) Clearance)

K220153 · Bozhou Rongjian Medical Appliance Co., Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2022
Decision
58d
Days
-
Risk

K220153 is an FDA 510(k) clearance for the Needle Stimulator (Model: RJNS6-1). Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Bozhou Rongjian Medical Appliance Co., Ltd. (Bozhou, CN). The FDA issued a Cleared decision on March 18, 2022 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bozhou Rongjian Medical Appliance Co., Ltd. devices

Submission Details

510(k) Number K220153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2022
Decision Date March 18, 2022
Days to Decision 58 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
90d faster than avg
Panel avg: 148d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWK Stimulator, Electro-acupuncture
Device Class -