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510(k) K771030

FLEXION MITTENS by Stat Medical Corp. — Product Code IOD

K771030 is an FDA 510(k) premarket notification submitted by Stat Medical Corp. for the device "FLEXION MITTENS". The FDA issued a decision of Substantially Equivalent on June 27, 1977. The device falls under product code IOD (Components, Exercise), a Class I device regulated under 21 CFR 890.5350. Stat Medical Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1977
Date Received
June 9, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Components, Exercise
Device Class
Class I
Regulation Number
890.5350
Review Panel
PM
Submission Type

Other clearances by Stat Medical Corp.

  • K780171 — ELBOW PROTECTOR (February 6, 1978)
  • K771031 — STROKE SLING (June 27, 1977)
  • K770853 — STERILE COTTON (May 23, 1977)

Other clearances for product code IOD

  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (June 24, 1983)
  • K823648 — SURGICAL TUBING (January 21, 1983)
  • K823822 — ANKLE WEIGHTS (January 14, 1983)
  • K823600 — SOLID WOOD CONE (December 22, 1982)
  • K813632 — COLOR CODED WEIGHT CUFFS (January 19, 1982)
  • K812319 — THERAPY BENCH (August 31, 1981)
  • K790587 — CANVAS WEDGE (April 3, 1979)
  • K772414 — SANDBAGS, VARIOUS WEIGHTS (February 1, 1978)
  • K761119 — SHEET METAL CLAMP (December 2, 1976)
  • K761118 — HAND SCREW CLAMP (December 2, 1976)

FDA data resources