FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARUKYR-BAN / HOT OR HEAT PACK
K Number: K850566
·
Decision May 29, 1985
Classifications
1
FEI Numbers
377
Registration Numbers
377
Same Product Code
81
Applicant Total
6
Review Days
106
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Basic Information
- Device Name
- MARUKYR-BAN / HOT OR HEAT PACK
- K Number
- K850566
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Oriental Medical Supplies, Inc.
- Date Received
- February 12, 1985
- Decision Date
- May 29, 1985
- Product Code
- IMD
- 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 |
|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | FDA class 1 | Physical Medicine |
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Other Clearances by Oriental Medical Supplies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893372 | LATEX EXAMINATION GLOVES | Aug 21, 1989 | Substantially Equivalent |
| K871666 | MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR | Jun 25, 1987 | Substantially Equivalent |
| K853442 | MODEL 804 (TENS) | Dec 9, 1985 | Substantially Equivalent |
| K853416 | MES-TENS(TENS) | Nov 7, 1985 | Substantially Equivalent |
| K852610 | HOT PACK | Aug 12, 1985 | Substantially Equivalent |