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Wireless app mode - Kit SPM01K3

by Ncs Lab SRL

Wireless app mode - Kit SPM01K3 is a medical device (FDA Class II) made by Ncs Lab SRL, listed in FDA GUDID since 1 Sep 2021 (UDI-DI 08051122040964), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08051122040964 UDI-DI Date1 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Wireless app mode - Kit
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Ref / Catalog
SPM01K3
Primary DI / UDI-DI
08051122040964
FDA product code
IPF, KQX, HCC
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class II
Regulation number
890.5850, 888.1500, 882.5050
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from Ncs Lab SRL

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Properties

  • Prescription use
  • Convenience kit
  • Serial number
Other properties (12, all answered No)