510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Heelbo, Inc.

Libertyville, IL, US

Heelbo, Inc. appears in FDA device records in Libertyville, IL. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
14
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 14 510(k) clearances for Heelbo, Inc. between 1996 and 1998. The busiest year on record is 1996, with 13. The most recent is 1998, with 1.

Clearances by year, as a table
510(k) clearance decisions for Heelbo, Inc., by decision year
YearClearances
199613
19981
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K980640HEELBO WAIST AND CHEST VESTFMQSubstantially Equivalent
K963372HEELBO ER WRIST RESTRAINTFMQSubstantially Equivalent
K963060HEELBO SECURITY BELTFMQSubstantially Equivalent
K963099HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKETFMQSubstantially Equivalent
K963041HEELBO LIFE JACKET WITH CROTCH SUPPORTFMQSubstantially Equivalent
K962839HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAPFMQSubstantially Equivalent
K962834HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAPFMQSubstantially Equivalent
K962832HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAPFMQSubstantially Equivalent
K962831THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSUREFMQSubstantially Equivalent
K963294HEELBO WRAP AROUND VESTFMQSubstantially Equivalent
K963237HEELBO ICU 911 BLAZER SLEEVED JACKETFMQSubstantially Equivalent
K962810GREAT HANDS MITTSFMQSubstantially Equivalent
K962778THE L-BOW ARM RESTRAINTFMQSubstantially Equivalent
K963243HEELBO BLAZER SLEEVED JACKETFMQSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

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