Rs- LB Low Back Conductive Garment, Model Rs-Lbm, Rs-Lbl, Rs-Fbg Full Back Conductive Garment , Model Rs-Fbg
FDA 510(k) K090951 · Rs Medical
510(k) numberK090951
Submission
- Device name
- Rs- LB Low Back Conductive Garment, Model Rs-Lbm, Rs-Lbl, Rs-Fbg Full Back Conductive Garment , Model Rs-Fbg
- Applicant
- Rs Medical
Vancouver, WA, US - Received
- April 3, 2009
- Decision date
- June 5, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Rs- LB Low Back Conductive Garment, Model Rs-Lbm, Rs-Lbl, Rs-Fbg Full Back Conductive Garment , Model Rs-Fbg cleared by the FDA?
Rs- LB Low Back Conductive Garment, Model Rs-Lbm, Rs-Lbl, Rs-Fbg Full Back Conductive Garment , Model Rs-Fbg (K090951) received a 510(k) decision of Substantially Equivalent on June 5, 2009, 63 days after the submission was received.
What is the product code of K090951?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.