FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLEXIMATIC MASSAGER
K Number: K852944
·
Decision Sep 5, 1985
Classifications
1
FEI Numbers
759
Registration Numbers
759
Same Product Code
99
Applicant Total
9
Review Days
56
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Basic Information
- Device Name
- FLEXIMATIC MASSAGER
- K Number
- K852944
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- General Physiotherapy, Inc.
- Date Received
- July 11, 1985
- Decision Date
- September 5, 1985
- 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 General Physiotherapy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K870939 | VIBRACARE | Apr 6, 1987 | Substantially Equivalent |
| K863383 | FACIAL MASSAGER, BATTERY POWERED | Sep 15, 1986 | Substantially Equivalent |
| K861834 | THERACUSHION MODEL 1000 | May 27, 1986 | Substantially Equivalent |
| K855129 | NEOCUSSOR (MASSAGER, BATTERY) POWERED | Jan 23, 1986 | Substantially Equivalent |
| K853710 | THERACUSHION | Jan 3, 1986 | Substantially Equivalent |
| K850047 | SANYO ELECTRONIC MUSCLE STIMULATORS | Mar 5, 1985 | Substantially Equivalent |
| K844591 | MIST-EASE NEBULIZER | Dec 13, 1984 | Substantially Equivalent |
| K810244 | PORTA-PULS MUSCLE STIMULATOR | Feb 26, 1981 | Substantially Equivalent |