Cleared Traditional

K211823 - Bonine Acupressure Bands (FDA 510(k) Clearance)

K211823 · Wellspring Pharmaceutical Corporation · Neurology device
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Sep 2021
Decision
79d
Days
-
Risk

K211823 is an FDA 510(k) clearance for the Bonine Acupressure Bands. Classified as Device, Acupressure (product code MVV).

Submitted by Wellspring Pharmaceutical Corporation (Sarasota, US). The FDA issued a Cleared decision on September 1, 2021 after a review of 79 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 Wellspring Pharmaceutical Corporation devices

Submission Details

510(k) Number K211823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2021
Decision Date September 01, 2021
Days to Decision 79 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
69d faster than avg
Panel avg: 148d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVV Device, Acupressure
Device Class -

Regulatory Consultant

Drug Device Consulting
Mikel Alberdi

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.