FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JAS Pulse(TM) Ultrasonic Therapy
K Number: K161628
·
Decision Nov 10, 2016
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
12
Review Days
150
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Basic Information
- Device Name
- JAS Pulse(TM) Ultrasonic Therapy
- K Number
- K161628
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bonutti Research, Inc.
- Date Received
- June 13, 2016
- Decision Date
- November 10, 2016
- Product Code
- IMI
- 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 |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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|---|---|---|---|
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| K062820 | UNITY ALPHA SYSTEM | Mar 15, 2007 | Substantially Equivalent |
| K060283 | TRANSET SYSTEM | Feb 22, 2006 | Substantially Equivalent |
| K052799 | MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM | Dec 16, 2005 | Substantially Equivalent |
| K033717 | TRANSET FRACTURE FIXATION SYSTEM | Feb 25, 2004 | Substantially Equivalent |
| K013177 | MULTITAK SUTURE SNAP SYSTEM | Dec 19, 2001 | Substantially Equivalent |
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