FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIDO V-TAK
K Number: K924512
·
Decision May 12, 1993
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
26
Applicant Total
9
Review Days
250
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Basic Information
- Device Name
- LIDO V-TAK
- K Number
- K924512
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5360
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Loredan Biomedical, Inc.
- Date Received
- September 4, 1992
- Decision Date
- May 12, 1993
- Product Code
- LXJ
- 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 |
|---|---|---|---|
| LXJ | Interactive Rehabilitation Exercise Devices | FDA class 2 | Physical Medicine |
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Other Clearances by Loredan Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924513 | LIDO(R) LINEA | Mar 31, 1993 | Substantially Equivalent |
| K903429 | LIDO LINEA | Aug 14, 1990 | Substantially Equivalent |
| K884487 | LIDO TM ACTIVE BACK | Nov 18, 1988 | Substantially Equivalent |
| K880018 | LIDO(TM) WORKSET | Feb 26, 1988 | Substantially Equivalent |
| K880017 | LIDO(TM) LIFT | Feb 26, 1988 | Substantially Equivalent |
| K871793 | LIDO ACTIVE | Jun 5, 1987 | Substantially Equivalent |
| K861986 | LIDO BACK | Jun 2, 1986 | Substantially Equivalent |
| K832770 | LANE ONE | Sep 26, 1983 | Substantially Equivalent |