FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE
K Number: K850332
·
Decision May 1, 1985
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
159
Applicant Total
71
Review Days
93
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Basic Information
- Device Name
- KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE
- K Number
- K850332
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Richards Medical Co., Inc.
- Date Received
- January 28, 1985
- Decision Date
- May 1, 1985
- Product Code
- BXB
- 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 |
|---|---|---|---|
| BXB | Exerciser, Powered | FDA class 1 | Physical Medicine |
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Other Clearances by Richards Medical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896106 | ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS | Jun 25, 1990 | Substantially Equivalent for Some Indications |
| K900628 | MODULAR HIP SYSTEM | May 9, 1990 | Substantially Equivalent for Some Indications |
| K896580 | UNI-POLAR HEAD | Feb 15, 1990 | Substantially Equivalent |
| K895241 | INTRAMEDULLARY HIP SCREW | Jan 4, 1990 | Substantially Equivalent |
| K884824 | TRICON-M TOTAL KNEE SYSTEM | Nov 21, 1989 | Substantially Equivalent for Some Indications |
| K896204 | ZIRCONIA CERAMIC HEAD ADD'L SIZES | Nov 20, 1989 | Substantially Equivalent for Some Indications |
| K895242 | PAPPAS TRI-FLANGE VENTILATION TUBE | Nov 17, 1989 | Substantially Equivalent |
| K893377 | RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS | Nov 16, 1989 | Substantially Equivalent |
| K885069 | ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) | Sep 1, 1989 | Substantially Equivalent for Some Indications |
| K892366 | POROUS GENESIS STEMMED TIBIAL COMPONENT | Jul 19, 1989 | Substantially Equivalent for Some Indications |