FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXERCISER, LEG, LOWER EXTREMITY
K Number: K770658
·
Decision Jun 17, 1977
Classifications
1
FEI Numbers
248
Registration Numbers
248
Same Product Code
42
Applicant Total
5
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EXERCISER, LEG, LOWER EXTREMITY
- K Number
- K770658
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5370
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Robert R. Moore
- Date Received
- April 7, 1977
- Decision Date
- June 17, 1977
- Product Code
- ION
- 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 |
|---|---|---|---|
| ION | Exerciser, Non-Measuring | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ION), ordered by most recent decision date.
ABLE-X
FDA 510(k)
FDA Class 1
·Physical Medicine
STANDEX
FDA 510(k)
FDA Class 1
·Physical Medicine
GRAVITY KING (DEEMED SE 87/09/18)
FDA 510(k)
FDA Class 1
·Physical Medicine
MOBILIZER
FDA 510(k)
FDA Class 1
·Physical Medicine
KNEE WALKER
FDA 510(k)
FDA Class 1
·Physical Medicine
FITNESS
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Robert R. Moore
| K Number | Device Name | ||
|---|---|---|---|
| K770501 | KNEE CUFF FOR EXPRESSING FLUID | Apr 5, 1977 | Substantially Equivalent |
| K770223 | HEAVY FOAM HEEL & ELBOW PROTECTORS | Feb 23, 1977 | Substantially Equivalent |
| K770060 | X-RAY POSITIONING DEVICE | Jan 24, 1977 | Substantially Equivalent |
| K770059 | ORTHOPEDIC SPECIALTIES | Jan 14, 1977 | Substantially Equivalent |