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N/A Ast-805B

by Shenzhen Osto Technology Co., Ltd.

Listed FDA GUDID listing, no authorization on record

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 Number06950940802971 UDI-DI Date30 Jul 2026ListedStatusListed GUDID: 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  • Withdrawn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

Generic Name
Analgesic transcutaneous electrical nerve stimulation system
Model / Reference
AST-805B
Primary DI / UDI-DI
06950940802971
510(k) Number
FDA Product Code
OLP, OHS
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K213056)

Show all (9)

Other devices from Shenzhen Osto Technology Co., Ltd.

See all devices from Shenzhen Osto Technology Co., Ltd. →

Properties

  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: 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