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)

Shoulder Pacemaker

K-Number: K210674 · 2021-08-24

ApplicantNcs Lab Srl
Decision Date2021-08-24
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Shoulder Pacemaker is the device name listed in this FDA 510(k) record. The listed applicant is Ncs Lab Srl. It received FDA 510(k) clearance on 2021-08-24 under 510(k) number K210674. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shoulder Pacemaker?

Shoulder Pacemaker is a medical device that received FDA 510(k) clearance on 2021-08-24. The listed applicant is Ncs Lab Srl. The 510(k) number is K210674.

When did Shoulder Pacemaker receive FDA 510(k) clearance?

Shoulder Pacemaker received FDA 510(k) clearance on 2021-08-24, under 510(k) number K210674.

Who is the listed applicant for Shoulder Pacemaker?

The FDA 510(k) record lists Ncs Lab Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shoulder Pacemaker?

The FDA product code for Shoulder Pacemaker is IPF.

Related Clinical Trials

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.

NCT05116722Shoulder Pacemaker for Scapular DyskinesiaENROLLING_BY_INVITATIONNCT06501859Rehabilitation With the Shoulder PacemakerENROLLING_BY_INVITATION

Other records listing Ncs Lab Srl 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.

K220994Shoulder PacemakerTMK160500Elite SPK, Compasso, Elite SPK Kit

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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.

↑