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Shoulder Pacemaker

by Ncs Lab SRL

510(k) K210674

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210674 Date24 Aug 2021ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IPF
Device class
Class II
Regulation
21 CFR Part 890.5850
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Shoulder Pacemaker is a device designed to help restore proper shoulder function, with applicability in rehabilitation related to pathology or surgery. It is classified under the product code IPF. The device is manufactured by NCS Lab Srl.

The Shoulder Pacemaker is supplied by NCS Lab Srl, with authorizations including FDA 510K. The device has a unique k number, K210674, and is associated with the advisory committee for Physical Medicine. The manufacturer is based in Italy, with certifications including UNI EN ISO 9001:2015 and UNI EN ISO 13485:2016.

Similar devices

Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).

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