Identity
- Trade Name
- RS-FBG-O Full Back Garment Only FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- RS-FBG Full Back Garment Only and treatment electrodes FDA UDI
- Model / Reference
- 959-0056-00 FDA UDI
- Description
- RS-FBG Full Back Garment Only and treatment electrodes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850814007210 FDA UDI
- 510(k) Number
- K090951 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
RS-FBG-O Full Back Garment Only by Rs Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K090951 also covers:
- RS-CFBG Conductive Full Back Garment — Rs Medical
- RS-CLBG Conductive Low Back Garment — Rs Medical
- RS-FBG Full Back Conductive Garment — Rs Medical
- RS-FBG Full Back Garment — Rs Medical
- RS-LB Low Back Conductive Garment — Rs Medical
- RS-LBG Low Back Garment — Rs Medical
- RS-LBG-O Low Back Garment Only — Rs Medical
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
- Rs Medical
Sources (1)
- FDA UDI 8eca883d-c1a8-4e0e-9255-2cc3ce6574c3 35 fields · synced Jun 1, 2026