RT300-SL, Model FA100052; RT300-SLSA, Model FA104581
FDA 510(k) K090750 · Restorative Therapies, Inc.
510(k) numberK090750
Submission
- Device name
- RT300-SL, Model FA100052; RT300-SLSA, Model FA104581
- Applicant
- Restorative Therapies, Inc.
Baltimore, MD, US - Received
- March 20, 2009
- Decision date
- August 5, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was RT300-SL, Model FA100052; RT300-SLSA, Model FA104581 cleared by the FDA?
RT300-SL, Model FA100052; RT300-SLSA, Model FA104581 (K090750) received a 510(k) decision of Substantially Equivalent on August 5, 2009, 138 days after the submission was received.
What is the product code of K090750?
The FDA product code is GZI – Stimulator, Neuromuscular, External Functional, a Class II (moderate risk) device regulated under 21 CFR 882.5810.