Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RSHOCK

K-Number: K220014 · 2023-03-01

Decision Date2023-03-01
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RSHOCK is the device name listed in this FDA 510(k) record. The listed applicant is Swims America Corp. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K220014. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSHOCK?

RSHOCK is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Swims America Corp. The 510(k) number is K220014.

When did RSHOCK receive FDA 510(k) clearance?

RSHOCK received FDA 510(k) clearance on 2023-03-01, under 510(k) number K220014.

Who is the listed applicant for RSHOCK?

The FDA 510(k) record lists Swims America Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RSHOCK?

The FDA product code for RSHOCK is PBX.

Other records listing Swims America Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.