Identity
- Trade Name
- Medical Science Products Private Label FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- 1.25" Round Foam FDA UDI
- Model / Reference
- 203-482 FDA UDI
- Description
- 1.25" Round Foam FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00092237900468 FDA UDI
- 510(k) Number
- K050469 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
Medical Science Products Private Label by Compass Health Brands Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transcutaneous electrical stimulation electrode, single-use.
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
- TMR-ELEC-20003221 2" WH Round electrode — Emsi · Class II
- Medical Science Products — SAUVRE INTERNATIONAL, LTD. · Class II
- AdvanTrode — PEPIN MANUFACTURING, INC. · Class II
- 3x5 fabric conductive pad — BioMedical Life Systems Inc. · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
- ProPatch — PRO MEDICAL SUPPLIES, INC. · Class II
- HealthmateForever — HEALTHMATE INTERNATIONAL, LLC · Class II
Cleared under the same submission
K050469 also covers:
- EZ-Stick — COMPASS HEALTH BRANDS CORP.
- EZ-Stick — COMPASS HEALTH BRANDS CORP.
- Karatrode — COMPASS HEALTH BRANDS CORP.
- Karatrode — COMPASS HEALTH BRANDS CORP.
- LSI Silver Self Adhesive, Disposable Electrodes — COMPASS HEALTH BRANDS CORP.
- LSI Silver Self Adhesive, Disposable Electrodes — COMPASS HEALTH BRANDS CORP.
- LSI Silver Self Adhesive, Disposable Electrodes — COMPASS HEALTH BRANDS CORP.
- Medi-Trode Platinum — COMPASS HEALTH BRANDS CORP.
- Medi-Trode Platinum — COMPASS HEALTH BRANDS CORP.
- Medical Science Private Label — COMPASS HEALTH BRANDS CORP.
- MultiStim Electrodes — COMPASS HEALTH BRANDS CORP.
- MultiStim Electrodes — COMPASS HEALTH BRANDS CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Compass Health Brands Corp.
Sources (1)
- FDA UDI b76d5048-f2f6-4580-8625-5ada0ae0c2a4 35 fields · synced Jun 8, 2026