Span-America Medical Systems, Inc.
Greenville, SC, US
SPAN-AMERICA MEDICAL SYSTEMS, INC. appears in FDA device records in Greenville, SC. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Span-America Medical Systems, Inc. between 1980 and 1998. The busiest year on record is 1996, with 6. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1985 | 1 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 2 |
| 1993 | 1 |
| 1995 | 3 |
| 1996 | 6 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973169 | PRESSURE GUARD SITE SELECT (A) | FNM | Substantially Equivalent | |
| K972486 | PRESSUREGUARD IV | IKZ | Substantially Equivalent | |
| K960188 | PRESSUREGUARD: SELECTCARE | FNM | Substantially Equivalent | |
| K961502 | LUBRICATING JELLY, LOW VISCOSITY | KMJ | Substantially Equivalent | |
| K961159 | POWERED LOW AIR LOSS MATTRESS SYSTEM | FNM | Substantially Equivalent | |
| K960620 | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM | FNM | Substantially Equivalent | |
| K960189 | GEL-T CUSHION | KIC | Substantially Equivalent | |
| K954766 | PRESSURE GUARD ALTERNATING PRESSURE MATTRESS | FNM | Substantially Equivalent | |
| K953503 | PRESSUREGUARD IV | FNM | Substantially Equivalent | |
| K954117 | CUSTOMCARE SEATING SYSTEM | KIC | Substantially Equivalent | |
| K951112 | PRESSUREGUARD IV | FNM | Substantially Equivalent | |
| K932681 | PRESSUREGUARD IV | FNM | Substantially Equivalent | |
| K894791 | BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE | LKB | Substantially Equivalent | |
| K893958 | BAXTER ACETONE-ALCOHOL PREP PADS, STERILE | LKB | Substantially Equivalent | |
| K882506 | MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 | KMJ | Substantially Equivalent | |
| K870742 | AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G | KMJ | Substantially Equivalent | |
| K870718 | AMERICAN ALCOHOL PREP PAD STERILE MEDIUM | LKB | Substantially Equivalent | |
| K854255 | SPAN / AID SYRINGE | FMF | Substantially Equivalent | |
| K801518 | SPAN-AID BRIDGING PILLOW SYSTEM | HKX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1041130 | 1041130 | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 70 Commerce Ctr, GREENVILLE, SC 29615 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IKXAid, Transfer
- HSTApparatus, Traction, Non-Powered
- IKZBed, Patient Rotation, Powered
- FMWCover, Mattress (Medical Purposes)
- KICCushion, Flotation
- IMPCushion, Wheelchair
- FSALift, Patient, Non-Ac-Powered
- KMJLubricant, Patient
- FNMMattress, Air Flotation, Alternating Pressure
- IKYMattress, Flotation Therapy, Non-Powered
- LKBPad, Alcohol, Device Disinfectant
- FMPProtector, Skin Pressure
- FRWScale, Patient
- INESling, Overhead Suspension, Wheelchair
- IOZSplint, Abduction, Congenital Hip Dislocation
- IOYSupport, Arm
- CCXSupport, Patient Position
- LWGSurgical Table Cushion
- FMFSyringe, Piston
- HKXTonometer, Ac-Powered
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain