FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROTONE
K Number: K974321
·
Decision Jun 22, 1998
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
72
Applicant Total
9
Review Days
217
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
- HYDROTONE
- K Number
- K974321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5100
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- North American Technical Services Corp.
- Date Received
- November 17, 1997
- Decision Date
- June 22, 1998
- Product Code
- ILJ
- 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 |
|---|---|---|---|
| ILJ | Bath, Hydro-Massage | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILJ), ordered by most recent decision date.
PARKER 500
FDA 510(k)
FDA Class 2
·Physical Medicine
IMMERSION HYDROBATH
FDA 510(k)
FDA Class 2
·Physical Medicine
MBATH 1000 (60)
FDA 510(k)
FDA Class 2
·Physical Medicine
PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
SUPERIOR BATH, MODEL 6300
FDA 510(k)
FDA Class 2
·Physical Medicine
CASCADE BATH, MODEL 6900
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by North American Technical Services Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K944730 | MASSAGER | Feb 14, 1995 | Substantially Equivalent for Some Indications |
| 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 |