FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
MASSAGER
K Number: K944730
·
Decision Feb 14, 1995
Classifications
1
FEI Numbers
759
Registration Numbers
759
Same Product Code
99
Applicant Total
9
Review Days
141
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Basic Information
- Device Name
- MASSAGER
- K Number
- K944730
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- North American Technical Services Corp.
- Date Received
- September 26, 1994
- Decision Date
- February 14, 1995
- 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 North American Technical Services Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K974321 | HYDROTONE | Jun 22, 1998 | Substantially Equivalent |
| K970592 | N/A | Jun 13, 1997 | Substantially Equivalent |
| K970590 | N/A | Jun 13, 1997 | Substantially Equivalent |
| K961582 | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 | Nov 8, 1996 | Substantially Equivalent |
| K953440 | ELLMAN LAPTRODE | Aug 29, 1995 | Substantially Equivalent |
| K944558 | ELLMAN VAPOR-VAC II | Apr 28, 1995 | Substantially Equivalent |
| K932204 | E-Z THERM 3 SECOND THERMOMETER | Oct 3, 1994 | Substantially Equivalent |
| K914364 | ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. | Sep 10, 1992 | Substantially Equivalent |