FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEOCUSSOR (MASSAGER, BATTERY) POWERED
K Number: K855129
·
Decision Jan 23, 1986
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
57
Applicant Total
9
Review Days
31
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Basic Information
- Device Name
- NEOCUSSOR (MASSAGER, BATTERY) POWERED
- K Number
- K855129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- General Physiotherapy, Inc.
- Date Received
- December 23, 1985
- Decision Date
- January 23, 1986
- Product Code
- BYI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BYI | Percussor, Powered-Electric | FDA class 2 | Anesthesiology |
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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 |
| K853710 | THERACUSHION | Jan 3, 1986 | Substantially Equivalent |
| K852944 | FLEXIMATIC MASSAGER | Sep 5, 1985 | 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 |