FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL
K Number: K072256
·
Decision Mar 12, 2008
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
8
Applicant Total
17
Review Days
212
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Basic Information
- Device Name
- HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL
- K Number
- K072256
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hill Laboratories Co.
- Date Received
- August 13, 2007
- Decision Date
- March 12, 2008
- Product Code
- PFW
- 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 |
|---|---|---|---|
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Hill Laboratories Co.
| K Number | Device Name | ||
|---|---|---|---|
| K090250 | ELECTRO-LIGHT THERAPY | Feb 11, 2010 | Substantially Equivalent |
| K083183 | AKLARUS PHOTOTHERAPY SYSTEM | Jul 16, 2009 | Substantially Equivalent |
| K062256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM | Feb 26, 2007 | Substantially Equivalent |
| K063034 | AIR-FLEX WITH AUTO-DISTRACTION | Dec 14, 2006 | Substantially Equivalent |
| K043239 | HEALTHSTAR ELITE | Dec 22, 2004 | Substantially Equivalent |
| K952357 | THE HILL ADJUSTABLE PODIATRY MODEL | Jul 6, 1995 | Substantially Equivalent |
| K952355 | THE HILL ADJUSTABLE 90MD | Jun 22, 1995 | Substantially Equivalent |
| K952358 | THE HILL ADJUSTABLE P.T. MOBILIZATION TABLE | Jun 22, 1995 | Substantially Equivalent |
| K942109 | THE HILL ADJUSTABLE RATH MECHANICAL TABLE | Jun 22, 1995 | Substantially Equivalent |
| K942256 | THE HILL ADJUSTABLE EXTEND-R TABLE | Jun 22, 1995 | Substantially Equivalent |