FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WM10, WM20, WM30 POWER MASSAGER
K Number: K862041
·
Decision Jun 17, 1986
Classifications
1
FEI Numbers
759
Registration Numbers
759
Same Product Code
99
Applicant Total
14
Review Days
20
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Basic Information
- Device Name
- WM10, WM20, WM30 POWER MASSAGER
- K Number
- K862041
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Associated Mills, Inc.
- Date Received
- May 28, 1986
- Decision Date
- June 17, 1986
- 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 Associated Mills, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901459 | DS60 TOOTHBRUSH SANITIZER | Sep 17, 1990 | Substantially Equivalent |
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| K871661 | WH150 ROOM HUMIDIFIER | Jun 15, 1987 | Substantially Equivalent |
| K862042 | SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER | Jun 5, 1986 | Substantially Equivalent |
| K844396 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 | Apr 18, 1985 | Substantially Equivalent |
| K844397 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 | Apr 18, 1985 | Substantially Equivalent |
| K850363 | POLLENEX DIGITAL THERMOMETER T-225 | Feb 15, 1985 | Substantially Equivalent |
| K850362 | POLLENEX DIGITAL THERMOMETER T-125 | Feb 15, 1985 | Substantially Equivalent |
| K841095 | BP800, 850 1000 | Aug 24, 1984 | Substantially Equivalent |
| K841100 | HP-20, 30, 40, 50 & 60 | Mar 23, 1984 | Substantially Equivalent |