The following data is part of a premarket notification filed by Rs Medical with the FDA for Rs- Lb Low Back Conductive Garment, Model Rs-lbm, Rs-lbl, Rs-fbg Full Back Conductive Garment , Model Rs-fbg.
| Device ID | K090951 |
| 510k Number | K090951 |
| Device Name: | RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG |
| Classification | Electrode, Cutaneous |
| Applicant | RS MEDICAL 14401 S.E. FIRST ST. Vancouver, WA 98684 |
| Contact | Timothy Johnson |
| Correspondent | Marc Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-03 |
| Decision Date | 2009-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850814007050 | K090951 | 000 |
| 00850814007036 | K090951 | 000 |
| 00850814007029 | K090951 | 000 |
| 00850814007005 | K090951 | 000 |
| 00850814007159 | K090951 | 000 |
| 00850814007142 | K090951 | 000 |
| 00850814007210 | K090951 | 000 |
| 00850814007203 | K090951 | 000 |