FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RTM REHABILITATION TREADMILL, MODEL #945-200
K Number: K930261
·
Decision May 26, 1993
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
20
Review Days
127
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Basic Information
- Device Name
- RTM REHABILITATION TREADMILL, MODEL #945-200
- K Number
- K930261
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biodan Medical Systems, Ltd.
- Date Received
- January 19, 1993
- Decision Date
- May 26, 1993
- Product Code
- IOL
- 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 |
|---|---|---|---|
| IOL | Treadmill, Powered | FDA class 1 | Physical Medicine |
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Other Clearances by Biodan Medical Systems, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K932153 | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME | Sep 7, 1993 | Substantially Equivalent |
| K930262 | TREATMENT TABLE, MODEL #825-100 | Mar 29, 1993 | Substantially Equivalent |
| K930259 | TRACTION TABLE MODEL #825-200 | Mar 24, 1993 | Substantially Equivalent |
| K926083 | NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES | Feb 12, 1993 | Substantially Equivalent |
| K926082 | CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT | Dec 30, 1992 | Substantially Equivalent |
| K922591 | UROLOGICAL C-ARM TABLE, MODEL #056-450 | Nov 27, 1992 | Substantially Equivalent |
| K922604 | DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE | Oct 20, 1992 | Substantially Equivalent |
| K922605 | TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 | Oct 20, 1992 | Substantially Equivalent |
| K923350 | CLOSED CHAIN ATTACHMENT, MODEL #820-520 | Jul 23, 1992 | Substantially Equivalent |
| K922772 | TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR | Jul 13, 1992 | Substantially Equivalent |