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actiTENS Mini KIT

by Sublimed

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 Number03770018808253 UDI-DI Date27 May 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  • Withdrawn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
actiTENS Mini
Generic Name
Analgesic transcutaneous electrical nerve stimulation system
Model / Ref / Catalog
actiTENS Mini KIT, SBM7AA011
Primary DI / UDI-DI
03770018808253
510(k) Number
FDA Product Code
GZJ, NYN, IPF, NGX, NUH
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system
Device Class
Class II
Regulation Number
882.5890, 890.5850
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K252767)

Other devices from Sublimed

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Properties

  • Prescription Use
  • Over-the-Counter
  • Convenience Kit
  • Serial Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No