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FDA 510(k)

RSHOCK

K-Number: K220014 · 2023-03-01

ApplicantSwims America Corp
Decision Date2023-03-01
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RSHOCK is a medical device manufactured by Swims America Corp. It received FDA 510(k) clearance on 2023-03-01 under approval 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. It is manufactured by Swims America Corp. The 510(k) number is K220014.

When was RSHOCK approved by the FDA?

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

What company makes RSHOCK?

RSHOCK is manufactured by Swims America Corp.

What is the FDA product code for RSHOCK?

The FDA product code for RSHOCK is PBX.

Other Devices by Swims America Corp

K214090Back 3 COLOR K230167BACK 4 K230037BACK 3

Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, Ltd.

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.

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