FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇭🇰 Hong Kong
DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B
K Number: K944884
·
Decision Feb 14, 1995
Classifications
1
FEI Numbers
759
Registration Numbers
759
Same Product Code
99
Applicant Total
2
Review Days
134
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Basic Information
- Device Name
- DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B
- K Number
- K944884
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Kolvin Industries , Ltd.
- Date Received
- October 3, 1994
- Decision Date
- February 14, 1995
- Product Code
- ISA
- 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 |
|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | FDA class 1 | Physical Medicine |
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Other Clearances by Kolvin Industries , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K944885 | DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000 | Feb 14, 1995 | Substantially Equivalent for Some Indications |