FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
K Number: K071486
·
Decision Sep 10, 2007
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
10
Review Days
103
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Basic Information
- Device Name
- RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
- K Number
- K071486
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5810
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Restorative Therapies, Inc.
- Date Received
- May 30, 2007
- Decision Date
- September 10, 2007
- Product Code
- GZI
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | FDA class 2 | Neurology |
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Other Clearances by Restorative Therapies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K162470 | RT300 FES cycle ergometer | Jul 11, 2017 | Substantially Equivalent |
| K160614 | Xcite Clinical Station | Dec 16, 2016 | Substantially Equivalent |
| K103370 | RT200 | Apr 5, 2011 | Substantially Equivalent |
| K103366 | RT600 | Apr 4, 2011 | Substantially Equivalent |
| K090750 | RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 | Aug 5, 2009 | Substantially Equivalent |
| K072398 | RT300-S AND RT300-SP FES CYCLE ERGOMETER | Nov 21, 2007 | Substantially Equivalent |
| K071113 | RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 | Jul 5, 2007 | Substantially Equivalent |
| K060032 | RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 | Mar 10, 2006 | Substantially Equivalent |
| K050036 | FES CYCLE ERGOMETER, MODEL RT300-S | Jun 27, 2005 | Substantially Equivalent |