ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)
FDA 510(k) clearance K880644 · decided 1988-05-06
Clearance details
- K-number
- K880644
- Device name
- ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)
- Applicant
- Fred Sammons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-02-16
- Decision date
- 1988-05-06
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- IRQ
- Device class
- 1
- Regulation number
- 890.5950
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Burr Ridge, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 (K050524) | Marda Medical, Inc. | 2005-09-14 |
| THEMALATOR. MODELS T-4-S, T-8-S, ETC. (K950350) | Whitehall/Div Columbus Mckennon Corp. | 1995-03-24 |
| FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 (K924023) | Ferno | 1993-04-14 |
| R1750 AND R1424 POWERED HEATING UNITS (K861340) | Tri W-G, Inc. | 1986-05-02 |
| PULSAIR MODEL SP-1 (K832177) | Thermowave Medical Device Corp. | 1983-12-09 |
| THERMOLATOR HEATING UNIT (K801625) | Tru-Eze Mfg. Co., Inc. | 1980-07-28 |
Recalls involving this device
No recalls on record reference this clearance.