FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BARS, PARALLEL, EXERCISE
K Number: K830466
·
Decision Mar 9, 1983
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
1
Applicant Total
12
Review Days
22
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Basic Information
- Device Name
- BARS, PARALLEL, EXERCISE
- K Number
- K830466
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5370
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Kaye Products, Inc.
- Date Received
- February 15, 1983
- Decision Date
- March 9, 1983
- Product Code
- IOE
- 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 |
|---|---|---|---|
| IOE | Bars, Parallel, Exercise | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IOE), ordered by most recent decision date.
View allOther Clearances by Kaye Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924848 | KAYE SCOOT-ABOUT, MODEL SB1 | Feb 12, 1993 | Substantially Equivalent |
| K923095 | KAYE MODEL KIAO PELVIC/THIGH STABILIZER | Jul 21, 1992 | Substantially Equivalent |
| K922061 | CHAIR, ADJUSTABLE, MECHANICAL | May 26, 1992 | Substantially Equivalent |
| K885330 | WHEELCHAIR, MECHANICAL | Feb 3, 1989 | Substantially Equivalent |
| K833869 | CHILD'S WALKER | Nov 29, 1983 | Substantially Equivalent |
| K830560 | EXERCISER, PASSIVE, NON MEASURING | Mar 9, 1983 | Substantially Equivalent |
| K820591 | MECHANICAL CHAIR | Mar 15, 1982 | Substantially Equivalent |
| K812399 | CHAIR, ADJUSTABLE, MECHANICAL | Sep 14, 1981 | Substantially Equivalent |
| K812319 | THERAPY BENCH | Aug 31, 1981 | Substantially Equivalent |
| K810609 | PEDIATRIC POSITION HOLDER | Mar 20, 1981 | Substantially Equivalent |