FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODELS 4100 AND 4300 MULTITHERAPY
K Number: K945954
·
Decision Jan 19, 1995
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
65
Applicant Total
7
Review Days
44
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Basic Information
- Device Name
- MODELS 4100 AND 4300 MULTITHERAPY
- K Number
- K945954
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5880
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinalight, Inc.
- Date Received
- December 6, 1994
- Decision Date
- January 19, 1995
- Product Code
- JFB
- 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 |
|---|---|---|---|
| JFB | Table, Physical Therapy, Multi Function | FDA class 2 | Physical Medicine |
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Other Clearances by Spinalight, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K172536 | Atlas Percussion Adjusting Instrument | Jun 20, 2018 | Substantially Equivalent |
| K001476 | TORQUE INSTRUMENT, MODEL 8500 | Aug 4, 2000 | Substantially Equivalent |
| K955540 | HAND HELD ATLAS INSTRUMENT | Mar 4, 1996 | Substantially Equivalent |
| K946258 | MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT | Nov 20, 1995 | Substantially Equivalent |
| K933621 | HILO TABLE | Jan 7, 1994 | Substantially Equivalent |
| K933622 | FLEXION DISTRACTION TABLE | Jan 7, 1994 | Substantially Equivalent |