Atlas FDA

ION

43 FDA 510(k) clearances · Product code

22 daysmedian time to decision
71 days90th percentile
43clearances measured

FDA profile

Official device name
Exerciser, Non-Measuring
Device class
Class I (low risk)
Regulation
21 CFR 890.5370
Medical specialty
Physical Medicine
Flags
GMP exempt
Adverse events (MAUDE)
2003: 4 · 2004: 2 · 2007: 3 · 2009: 3 · 2011: 7 · 2013: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ABLE-X (K120783)Im-Able, Ltd.2012-06-20
STANDEX (K885343)Alt, Inc.1989-05-01
GRAVITY KING (DEEMED SE 87/09/18) (K851065)Unique Functional Products1985-06-13
MOBILIZER (K840551)Lossing Orthopedic, Inc.1984-03-23
KNEE WALKER (K833870)Maddak, Inc.1983-11-29
FITNESS (K833249)Fitness Equipment Co., Inc.1983-11-07
PEDAL EXERCISER (K832968)Maddak, Inc.1983-09-29
ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (K831543)Fred Sammons, Inc.1983-06-24
DELUXE ADJUST-ANGLE BOARD-BK4066 (K831538)Fred Sammons, Inc.1983-06-08
GIREX (K831033)Lancer Assoc.1983-04-27
MADDATRAINER HAND EXERCISER (K830400)Maddak, Inc.1983-03-09
EXERCISER, PASSIVE, NON MEASURING (K830560)Kaye Products, Inc.1983-03-09
BACK ON TRACK INVERSION THERAPY & EXER (K823236)Lossing Orthopedic, Inc.1983-01-21
INFLATABLE HEAVY PLASTIC EXERCISER (K823623)Fred Sammons, Inc.1982-12-28
PROGRESSIVE RESISTANCE EXERCISE CUFF (K823618)Fred Sammons, Inc.1982-12-22
PLASTIC ELASTOMER ENCASED IN TERRY CLOTH (K823619)Fred Sammons, Inc.1982-12-22
PLASTIC ELASTOMER IN CUBE FORM EXERCISE (K823620)Fred Sammons, Inc.1982-12-22
PHYSICAL MEDICINE & REHABILITATION EQUIP (K822906)I-Rep, Inc.1982-10-15
BK-5305 MULTIPLE HAND GRID (K821857)Fred Sammons, Inc.1982-07-02
VISCO HANDEX-VARIOUS MODELS (K821855)Fred Sammons, Inc.1982-07-02
MODELING COMPOUND AND FOAM EXERCISER (K813633)Fred Sammons, Inc.1982-01-19
BACK RIE (K813099)Back Rite1981-11-24
BABY WALKER W/TOY CHEST (K812474)Maddak, Inc.1981-09-14
NON-MEASURING EXERCISERS (K812351)Fred Sammons, Inc.1981-09-14
NON-MEASURING EXERCISERS (K810444)Fred Sammons, Inc.1981-03-04
BK-5315-01 FOAM HAND EXERCISER, SMALL (K801710)Fred Sammons, Inc.1980-08-07
FINGER, HAND & WRIST EXERCISER (K801453)Robert W. Slack1980-08-04
THE VARIABLE LOAD KENETIC ENERGIZER (K792642)W.F. Pogue1980-01-28
COLOR CODED PUTTY SOFT, REGULAR & FIRM (K800017)Fred Sammons, Inc.1980-01-21
LOUNGE, TILT-A-BODY STRETCH (K790572)Innovative Products, Inc.1979-04-10
PUSH BALL INCLINE (K790530)Maddak, Inc.1979-04-03
VISA-GRIP (K790191)Premier Sundries, Inc.1979-02-08
OBJECTS PRECISION HANDLING TEST KIT (K781350)Metro. Hospital & Health Center1978-10-17
FINGER EXERCISE BOARD (K772404)Fred Sammons, Inc.1978-02-13
EXERCISER, LEG, LOWER EXTREMITY (K770658)Robert R. Moore1977-06-17
EXERCISER, EXTENSOR WAND (K770436)Maddak, Inc.1977-04-06
RHEUMATOID HAND GYM (K770144)Maddak, Inc.1977-01-28
4-BAR KNEE-SHIN SET-UP (K761313)Hosmer Dorrance Corp.1977-01-10
FLEXION-BRAKING KNEE-SHIN ASSEMBLY (K761314)Hosmer Dorrance Corp.1977-01-10
SHORT INFLATED ROLLS (K761135)Fred Sammons, Inc.1976-12-02
SPIN-A-PULL (K761120)Fred Sammons, Inc.1976-12-02
BALLOONS, BK-8112, 8114 (K760305)Fred Sammons, Inc.1976-09-08
CANOPY, PARACHUTE, BK-8110 (K760304)Fred Sammons, Inc.1976-09-08

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Every clearance here is in the API, with alerts when new ones post.