FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇭 Switzerland
DolorClast Radial
K Number: K220538
·
Decision Jul 11, 2022
Classifications
1
FEI Numbers
783
Registration Numbers
783
Same Product Code
99
Applicant Total
6
Review Days
136
Basic Information
- Device Name
- DolorClast Radial
- K Number
- K220538
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EMS Electro Medical Systems SA
- Date Received
- February 25, 2022
- Decision Date
- July 11, 2022
- Product Code
- ISA
- 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 |
|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | FDA class 1 | Physical Medicine |
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Other Clearances by EMS Electro Medical Systems SA
| K Number | Device Name | ||
|---|---|---|---|
| K230893 | Swiss LthoClast Trilogy | Oct 23, 2023 | Substantially Equivalent |
| K191124 | Swiss LithoClast Trilogy | May 29, 2019 | Substantially Equivalent |
| K182490 | Swiss LithoClast Trilogy | Oct 9, 2018 | Substantially Equivalent |
| K181997 | Swiss LithoClast Trilogy | Aug 30, 2018 | Substantially Equivalent |
| K181364 | Swiss LithoClast Trilogy | Jun 20, 2018 | Substantially Equivalent |