FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI
K Number: K023050
·
Decision Feb 14, 2003
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
54
Applicant Total
19
Review Days
154
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Basic Information
- Device Name
- RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI
- K Number
- K023050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reliant Technologies, Inc.
- Date Received
- September 13, 2002
- Decision Date
- February 14, 2003
- Product Code
- IMG
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Reliant Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080915 | FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES | Jul 1, 2008 | Substantially Equivalent |
| K071051 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | Nov 2, 2007 | Substantially Equivalent |
| K071621 | RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES | Oct 9, 2007 | Substantially Equivalent |
| K070284 | FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) | May 17, 2007 | Substantially Equivalent |
| K063808 | FRAXEL IV SR LASER SYSTEM | Apr 27, 2007 | Substantially Equivalent |
| K063038 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | Apr 27, 2007 | Substantially Equivalent |
| K062303 | FRAXEL II SR LASER SYSTEM | Jan 31, 2007 | Substantially Equivalent |
| K060310 | FRAXEL II SR LASER SYSTEM AND ACCESSORIES | Mar 29, 2006 | Substantially Equivalent |
| K053047 | FRAXEL SR LASER SYSTEM | Mar 20, 2006 | Substantially Equivalent |
| K050841 | FRAXEL SR LASER SYSTEM | Jul 5, 2005 | Substantially Equivalent |