Richmar 400-858
Richmar 400-858 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 00850030915443), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850030915443 | Date2 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223775 | Date3 Jan 2023 | StatusActive |
Official records
- AccessGUDID record 00850030915443
- FDA 510(k) database K223775
Across registries
- FDA 510(k) K223775 decided 3 Jan 2023 Active
- FDA GUDID UDI-DI 00850030915443 listed 2 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K223775
- Listed FDA GUDID 00850030915443
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Richmar
- Generic name
- Transcutaneous electrical stimulation electrode, reusable
- Model / reference
- 400-858
- Primary DI / UDI-DI
- 00850030915443
- 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
Similar devices
Other devices filed under FDA product code GXY (Electrode, Cutaneous).
- Neuroline GroundNeurology Surface Electrodes 71410-M/1 by Ambu A/S
- Dexus Prosthetics System (Model: MSL1, MSR1) by Zhejiang Qiangnao Technology Co., Ltd
- K-STERILE TENS ELECTRODES by KATECHO LLC
- MR Conditional Sticky Pad Electrode by Rhythmlink International, LLC
- Adhesive Electrodes by Voncare Medical Device Co., Ltd
- DeltaScan Patch 009.000.B by Prolira BV
- BABE-EASE NEONATAL CLOTH ECG ELECTRODE by Labeltape Meditect, Inc.
- KM-30 TENS ELECTRODE by KATECHO LLC
- connectgrip. 560X27-1=ANDR by Otto Bock Healthcare Products GmbH
- EEG ELECTRODES by Bioscan, Inc.