FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Megapulse III Shortwave Diathermy
K Number: K153456
·
Decision Jun 14, 2016
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
44
Applicant Total
2
Review Days
196
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Basic Information
- Device Name
- Megapulse III Shortwave Diathermy
- K Number
- K153456
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Accelerated Care Plus
- Date Received
- December 1, 2015
- Decision Date
- June 14, 2016
- Product Code
- IMJ
- 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 |
|---|---|---|---|
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Accelerated Care Plus
| K Number | Device Name | ||
|---|---|---|---|
| K093600 | OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM | Dec 4, 2009 | Substantially Equivalent |