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Mobius Therapy KTR-201

by Endless Relief

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860074002207 UDI-DI Date30 Jun 2018ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Mobius Therapy
Generic Name
Analgesic transcutaneous electrical nerve stimulation system
Model / Reference
KTR-201
Primary DI / UDI-DI
00860074002207
510(k) Number
FDA Product Code
NUH
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system
Device Class
Class II
Regulation Number
882.5890
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K170205)

Properties

  • Over-the-Counter
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No