FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PORTA-PULS MUSCLE STIMULATOR
K Number: K810244
·
Decision Feb 26, 1981
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
64
Applicant Total
9
Review Days
29
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PORTA-PULS MUSCLE STIMULATOR
- K Number
- K810244
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- General Physiotherapy, Inc.
- Date Received
- January 28, 1981
- Decision Date
- February 26, 1981
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IRO), ordered by most recent decision date.
QI GONG MASSAGER
FDA 510(k)
FDA Class 1
·Physical Medicine
COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER
FDA 510(k)
FDA Class 1
·Physical Medicine
MASSAGER THERAPUTIC, ELECTRIC
FDA 510(k)
FDA Class 1
·Physical Medicine
SHIATSU MASTER MASSAGER CUSHION
FDA 510(k)
FDA Class 1
·Physical Medicine
CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
CONAIR FAMILY FITNESS BODY ENERGY
FDA 510(k)
FDA Class 1
·Physical Medicine
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 |
| 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 |