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Profile Applicator FLE0103

by SANUWAVE Health, Inc.

Profile Applicator FLE0103 is a medical device (FDA Class I; FDA product code ISA, Massager, Therapeutic, Electric) made by SANUWAVE Health, Inc., listed in FDA GUDID since 25 Jan 2021 (UDI-DI 00812265010294), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00812265010294 UDI-DI Date25 Jan 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  • Withdrawn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
Profile Applicator
Generic name
Dermatological extracorporeal shock wave therapy system applicator
Model / reference
FLE0103
Primary DI / UDI-DI
00812265010294
FDA product code
ISA
GMDN term
Dermatological extracorporeal shock wave therapy system applicator
Device class
Class I
Regulation number
890.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dermatological extracorporeal shock wave therapy system applicator

Similar devices

Other devices filed under FDA product code ISA (Massager, Therapeutic, Electric).

Other devices from SANUWAVE Health, Inc.

See all devices from SANUWAVE Health, Inc. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)