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Domas SM9067

by Hong Qiangxing (Shenzhen) Electronics Limited

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 Number06971712725922 UDI-DI Date13 Oct 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  • Withdrawn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
Domas
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Reference
SM9067
Primary DI / UDI-DI
06971712725922
510(k) Number
FDA Product Code
NGX, NUH, GZJ, IPF, NYN
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Class
Class II
Regulation Number
890.5850, 882.5890
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K233092)

Show all (12)

Other devices from Hong Qiangxing (Shenzhen) Electronics Limited

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Properties

  • Over-the-Counter
  • Manufacturing Date

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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No