FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A PHYSIOTHERAPY APPARATUS
K Number: K902803
·
Decision Feb 6, 1991
Classifications
1
FEI Numbers
423
Registration Numbers
423
Same Product Code
227
Applicant Total
2
Review Days
224
Basic Information
- Device Name
- A PHYSIOTHERAPY APPARATUS
- K Number
- K902803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- GRACE RIVER ENT., INC.
- Date Received
- June 27, 1990
- Decision Date
- February 6, 1991
- Product Code
- ILY
- 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | FDA class 2 | Physical Medicine |
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Other Clearances by GRACE RIVER ENT., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K891277 | PATIENT EXAMINATION GLOVES (LATEX) | Jan 11, 1990 | Substantially Equivalent |