FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHYSICAL MEDICINE & REHABILITATION EQUIP
K Number: K822906
·
Decision Oct 15, 1982
Classifications
1
FEI Numbers
248
Registration Numbers
248
Same Product Code
42
Applicant Total
8
Review Days
16
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Basic Information
- Device Name
- PHYSICAL MEDICINE & REHABILITATION EQUIP
- K Number
- K822906
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5370
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- I-Rep, Inc.
- Date Received
- September 29, 1982
- Decision Date
- October 15, 1982
- 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 |
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Other Clearances by I-Rep, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930692 | LATHAM TABLE | Feb 2, 1994 | Substantially Equivalent |
| K930691 | ACCUTRAC TRACTION UNIT | Jul 22, 1993 | Substantially Equivalent |
| K861864 | MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT | Jul 14, 1986 | Substantially Equivalent |
| K854947 | REHABILITATION TABLES | Jan 3, 1986 | Substantially Equivalent |
| K851690 | ADJUSTABLE TREATMENT TABLES | May 7, 1985 | Substantially Equivalent |
| K842268 | VACUPULSE VACUUM UNIT | Jul 20, 1984 | Substantially Equivalent |
| K832940 | ROTAGYM | Nov 7, 1983 | Substantially Equivalent |