FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Ballancer Gold, 1212
K Number: K190015
·
Decision Mar 25, 2019
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
152
Applicant Total
17
Review Days
81
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Basic Information
- Device Name
- Ballancer Gold, 1212
- K Number
- K190015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5650
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mego Afek AC , Ltd.
- Date Received
- January 3, 2019
- Decision Date
- March 25, 2019
- Product Code
- IRP
- 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 |
|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | FDA class 2 | Physical Medicine |
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Other Clearances by Mego Afek AC , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K214053 | Amputee Garment for use with Lympha Press Optimal Plus | Apr 14, 2022 | Substantially Equivalent |
| K190493 | Recovery Pump, 737R (RPX) | May 15, 2019 | Substantially Equivalent |
| K182003 | Lympha Press Optimal Plus | Feb 27, 2019 | Substantially Equivalent |
| K172277 | Phlebo Press DVT Model | Nov 3, 2017 | Substantially Equivalent |
| K170658 | Lympha Press Optimal Plus | May 31, 2017 | Substantially Equivalent |
| K163280 | RP Lite 760R | Jan 27, 2017 | Substantially Equivalent |
| K150269 | Ballancer 505 System, Model 1201-AC | May 26, 2015 | Substantially Equivalent |
| K142772 | Phlebo Press DVT 603 | Dec 16, 2014 | Substantially Equivalent |
| K140519 | RECOVERY PUMP 737R | Jun 16, 2014 | Substantially Equivalent |
| K140642 | PCD 737A | Jun 10, 2014 | Substantially Equivalent |