FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEALTH ESSENTIALS MAXI MASSAGER
K Number: K924581
·
Decision Oct 12, 1993
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
64
Applicant Total
29
Review Days
397
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Basic Information
- Device Name
- HEALTH ESSENTIALS MAXI MASSAGER
- K Number
- K924581
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Conair Corp.
- Date Received
- September 10, 1992
- Decision Date
- October 12, 1993
- Product Code
- IRO
- 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 |
|---|---|---|---|
| IRO | Vibrator, Therapeutic | FDA class 1 | Physical Medicine |
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Other Clearances by Conair Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K950441 | CONAIR FAMILY FITNESS BODY ENERGY | Jul 18, 1995 | Substantially Equivalent |
| K950410 | CONAIR BODY AND SOLE | May 23, 1995 | Substantially Equivalent |
| K944637 | FAMILY FITNESS SHIATSU MASSAGER | Dec 13, 1994 | Substantially Equivalent for Some Indications |
| K943730 | SQUEEZE PLAY | Nov 28, 1994 | Substantially Equivalent for Some Indications |
| K924970 | FEMININE HEAT WRAP | Oct 3, 1994 | Substantially Equivalent for Some Indications |
| K943092 | FAMILY FITNESS SHIATSU MASSAGER | Sep 29, 1994 | Substantially Equivalent |
| K942950 | BODY FLEX | Jul 26, 1994 | Substantially Equivalent for Some Indications |
| K942223 | BODY SYSTEM | Jun 9, 1994 | Substantially Equivalent for Some Indications |
| K940369 | BODY RECHARGER | Apr 21, 1994 | Substantially Equivalent for Some Indications |
| K926339 | BODY RELAXER | Mar 4, 1994 | Substantially Equivalent |