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Procomfort SM9075

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 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 Number06971712720125 UDI-DI Date10 Dec 2025ListedStatusListed 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  • Withdrawn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

Trade Name
Procomfort
Generic Name
Analgesic transcutaneous electrical nerve stimulation system
Model / Reference
SM9075
Primary DI / UDI-DI
06971712720125
510(k) Number
FDA Product Code
NGX, NUH, GZJ, IPF, NYN
GMDN Term
Analgesic transcutaneous electrical nerve 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

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: 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