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Sonik Sm-100

by Neuro Spinal Innovation, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00627987783506 UDI-DI Date8 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sonik
Generic Name
Electromechanical orthopaedic extracorporeal shock wave therapy system
Model / Ref / Catalog
SM-100
Primary DI / UDI-DI
00627987783506
510(k) Number
FDA Product Code
LXM
GMDN Term
Electromechanical orthopaedic extracorporeal shock wave therapy system
Device Class
U
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Neuro Spinal Innovation, Inc.

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No