FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE BTE DYNAMIC LIFT
K Number: K924414
·
Decision Feb 12, 1993
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
60
Applicant Total
7
Review Days
165
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Basic Information
- Device Name
- THE BTE DYNAMIC LIFT
- K Number
- K924414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1925
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Baltimore Therapeutic Equipment Co.
- Date Received
- August 31, 1992
- Decision Date
- February 12, 1993
- Product Code
- IKK
- 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 |
|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | FDA class 2 | Physical Medicine |
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Other Clearances by Baltimore Therapeutic Equipment Co.
| K Number | Device Name | ||
|---|---|---|---|
| K955106 | BTE CPM-20 | Dec 29, 1995 | Substantially Equivalent |
| K955105 | BTE CPM-10 | Dec 29, 1995 | Substantially Equivalent |
| K925225 | THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK | Jun 27, 1994 | Substantially Equivalent |
| K933611 | THE BTE WS30 | Jun 20, 1994 | Substantially Equivalent |
| K895881 | MOTIONSPECT | Apr 10, 1990 | Substantially Equivalent |
| K800007 | WORK SIMULATOR | Jan 21, 1980 | Substantially Equivalent |