Skip to content

SofWave Pure Impact Electode Pads FG00015

by Sofwave Medical Ltd Israel GUDID

Product code NGX

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17290018152154 UDI-DIDate7 Jan 2024ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
SofWave Pure Impact Electode Pads
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Ref / Catalog
FG00015
Primary DI / UDI-DI
17290018152154
510(k) Number
FDA Product Code
NGX
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Class
Class II
Regulation Number
890.5850
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system

Cleared under the same submission (K232455)

Cleared under the same submission (K241685)

Cleared under the same submission (K250146)

Cleared under the same submission (K251746)

Other devices from Sofwave Medical Ltd

See all devices from Sofwave Medical Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (1)

  • FDA UDI 15aa9924-9429-451a-91b6-79b9983050d9 36 fields · synced 23 Oct 2026