FDA 510(k)
FDA class 1
Substantially Equivalent
🇭🇰 Hong Kong
A101 LITESSAGER
K Number: K914830
·
Decision Dec 9, 1991
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
64
Applicant Total
13
Review Days
45
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Basic Information
- Device Name
- A101 LITESSAGER
- K Number
- K914830
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fairform Mfg., Co., Ltd.
- Date Received
- October 25, 1991
- Decision Date
- December 9, 1991
- 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 Fairform Mfg., Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K931640 | AO11 BODY MASSAGER | Mar 28, 1994 | Substantially Equivalent |
| K931636 | FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER | Mar 28, 1994 | Substantially Equivalent |
| K931638 | FO96 HANDY MASSAGER | Mar 28, 1994 | Substantially Equivalent |
| K931639 | F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR | Mar 28, 1994 | Substantially Equivalent |
| K931637 | A013 FEMI-FORM FACIAL MASSAGER | Mar 28, 1994 | Substantially Equivalent |
| K920644 | F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND | May 29, 1992 | Substantially Equivalent |
| K914704 | FO69 FANCY MASSAGER | Dec 9, 1991 | Substantially Equivalent |
| K914703 | F383 RECHARGEABLE MINI MASSAGER | Dec 9, 1991 | Substantially Equivalent |
| K914829 | FO92 SEATING MASSAGER | Dec 9, 1991 | Substantially Equivalent |
| K914706 | FO51/F151 GOLF MASSAGER | Dec 9, 1991 | Substantially Equivalent |