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FDA 510(k)

DolorClast Radial

K-Number: K220538 · 2022-07-11

ApplicantE.M.S Electro Medical Systems S.A
Decision Date2022-07-11
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DolorClast Radial is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2022-07-11 under 510(k) number K220538. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DolorClast Radial?

DolorClast Radial is a medical device that received FDA 510(k) clearance on 2022-07-11. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K220538.

When did DolorClast Radial receive FDA 510(k) clearance?

DolorClast Radial received FDA 510(k) clearance on 2022-07-11, under 510(k) number K220538.

Who is the listed applicant for DolorClast Radial?

The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DolorClast Radial?

The FDA product code for DolorClast Radial is ISA.

Other records listing E.M.S Electro Medical Systems S.A as applicant

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Related Devices (Code: ISA)

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.

K243488VMAT PROTermosaludK240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K210166Omnispec ED1000Medispec, Ltd.K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave TrtK210451OrthoGold 100Tissue Regeneration Technologies, LLC

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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