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Richmar 400-857

by South Dakota Partners

Richmar 400-857 is a Class II device made by South Dakota Partners, cleared under FDA 510(k) K223775 on 3 Jan 2023 and listed in FDA GUDID since 2 Aug 2023 (UDI-DI 00850030915436), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K223775

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850030915436 UDI-DI Date2 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223775 Date3 Jan 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223775 decided 3 Jan 2023 Active
  • FDA GUDID UDI-DI 00850030915436 listed 2 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223775
  2. Listed FDA GUDID 00850030915436

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Richmar
Generic name
Transcutaneous electrical stimulation electrode, reusable
Model / reference
400-857
Primary DI / UDI-DI
00850030915436
510(k) Number
FDA product code
GXY
GMDN term
Transcutaneous electrical stimulation electrode, reusable
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution

Related devices

Category: Transcutaneous electrical stimulation electrode, reusable

Cleared under the same submission (K223775)

and 8 more cleared under K223775

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

Other devices from South Dakota Partners

  • Richmar 400-898

    Class II

  • Richmar 400-866

    Class II

  • Richmar 400-864

    Class II

  • Richmar 400-899

    Class II

See all devices from South Dakota Partners →

Properties

  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)