FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
D function
K Number: K203525
·
Decision May 5, 2021
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
8
Review Days
155
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Basic Information
- Device Name
- D function
- K Number
- K203525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ito Co., Ltd.
- Date Received
- December 1, 2020
- Decision Date
- May 5, 2021
- Product Code
- NUW
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| NUW | Stimulator, Muscle, Powered, Dental | FDA class 2 | Physical Medicine |
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Other Clearances by Ito Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K112520 | US-101L, US-103S | Oct 26, 2011 | Substantially Equivalent |
| K081943 | MODEL ES-130 | Nov 24, 2008 | Substantially Equivalent |
| K081247 | TM-400 | Aug 25, 2008 | Substantially Equivalent |
| K032793 | US-100 PORTABLE ULTRASOUND THERAPY UNIT | Oct 9, 2003 | Substantially Equivalent |
| K022846 | SW-180 SHORTWAVE THERAPY UNIT | Jan 28, 2003 | Substantially Equivalent |
| K990787 | TRIO 300 | Oct 20, 1999 | Substantially Equivalent |
| K992545 | TM-300 TRACTION SYSTEM | Sep 1, 1999 | Substantially Equivalent |