FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUR FLO THERMAL THERAPY PADS
K Number: K930634
·
Decision Nov 1, 1993
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
111
Review Days
266
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
- SUR FLO THERMAL THERAPY PADS
- K Number
- K930634
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Buckman Co., Inc.
- Date Received
- February 8, 1993
- Decision Date
- November 1, 1993
- Product Code
- ILO
- 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 |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILO), ordered by most recent decision date.
Armory Motion
FDA 510(k)
FDA Class 2
·Physical Medicine
COOLSKIN
FDA 510(k)
FDA Class 2
·Physical Medicine
T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
FDA 510(k)
FDA Class 2
·Physical Medicine
JUNIPER CLN1 DERMAL COOLING DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO POLAR CARE 500
FDA 510(k)
FDA Class 2
·Physical Medicine
IVC SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Buckman Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961320 | CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM | Jun 25, 1998 | Substantially Equivalent |
| K974641 | FUTURELASE 3000/3002 ERBIUM LASER SYSTEM | Jun 8, 1998 | Substantially Equivalent |
| K964252 | ORTHOCHUCK | May 27, 1997 | Substantially Equivalent |
| K950099 | SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM | Jan 16, 1997 | Substantially Equivalent for Some Indications |
| K960451 | WEBB-MORLEY SPINE SYSTEM | Apr 18, 1996 | Substantially Equivalent for Some Indications |
| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | Jan 25, 1996 | Substantially Equivalent |
| K945756 | IMAGN(TM) 2000 SYSTEM | Dec 19, 1995 | Substantially Equivalent |
| K940003 | VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT | Oct 19, 1995 | Substantially Equivalent |
| K951117 | LIHTAN 532 LASER | Oct 18, 1995 | Substantially Equivalent |
| K942751 | VANGUARD SERIES GAS REGULATORS | Feb 9, 1995 | Substantially Equivalent |